Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I am looking for some advice.  What steps would you take to investigate a complaint if the complaint sample is not available for investigation and the lot/serial number is unknown?  The complaint involved the failure of a component.  The customer ordered the replacement part and replaced it themselves.  Your thoughts are appreciated.

Generally, a complaint cannot be verified unless there is actual investigation of the product and the problem is replicated.  In your scenario, the product was not returned so you could not physically evaluate trace the lot/serial number and review the device history record.  While this complaint could not be verified it is important to trend this reported occurrence and record it as non-verified.  Also consider risk in your assessment.  If in the future you have a number of the same reported occurrences this will need to be captured in your metrics and reviewed for corrective action and risk impact.

In the alternative to a full return of the product,  the faulty part could have been returned for investigation - with or without the serial number which would help to assess the problem/complaint.  Other questions: Are you able to force the occurrence of this problem with product existing in inventory?  Can you trace or approximate the sale or location of sale to hover in on the date of manufacturing, etc.

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Mary Ann Greenawalt
Regulatory Affairs
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Original Message:
Sent: 21-Feb-2017 07:06
From: Anonymous Member
Subject: Complaint Investigation

This message was posted by a user wishing to remain anonymous

I am looking for some advice.  What steps would you take to investigate a complaint if the complaint sample is not available for investigation and the lot/serial number is unknown?  The complaint involved the failure of a component.  The customer ordered the replacement part and replaced it themselves.  Your thoughts are appreciated.

You don't need the failed sample or lot number to investigate a failure. These are helpful to the manufacturing side of the investigation, but it's the clinical side that is key from a regulatory, rather than a QMS, perspective.  I would investigate as needed to determine the clinical circumstances and consequences of the failure, eg:

Was the product in clinical use (or being readied for use) at the time it failed?  If so, how did the failure affect the clinical procedure that was in process at the time?  Did this have any impact on the patient?  If so, what was that impact and how was it resolved?  If it didn't fail during clinical use, could it have done so?  In that case, same questions.

The main bar to the clinical side of the investigation is that the healthcare provider won't respond to your questions.   As a general rule, I like to see three documented efforts to get them answered (date and time of phone call, or an email is fine) in the complaint file.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 21-Feb-2017 07:06
From: Anonymous Member
Subject: Complaint Investigation

This message was posted by a user wishing to remain anonymous

I am looking for some advice.  What steps would you take to investigate a complaint if the complaint sample is not available for investigation and the lot/serial number is unknown?  The complaint involved the failure of a component.  The customer ordered the replacement part and replaced it themselves.  Your thoughts are appreciated.

If the failure occurred during use in a patient, for an AE to be valid and investigated it must have 4 minimum data elements: identifiable patient, identifiable reporter, suspect drug/device, and suspect AE.  You don't have to have a sample, but you do need a batch number.  Performing a technical complaint if it wasn't used in a patient may be a different story depending on your quality system instruction.  

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Amanda Broughton
Spokane WA
United States
------------------------------

Original Message:
Sent: 21-Feb-2017 07:06
From: Anonymous Member
Subject: Complaint Investigation

This message was posted by a user wishing to remain anonymous

I am looking for some advice.  What steps would you take to investigate a complaint if the complaint sample is not available for investigation and the lot/serial number is unknown?  The complaint involved the failure of a component.  The customer ordered the replacement part and replaced it themselves.  Your thoughts are appreciated.

Nice list of minimum required data elements, Amanda.  Did you draw them from a source, or is this what you have worked out from experience?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 23-Feb-2017 14:46
From: Amanda Broughton
Subject: Complaint Investigation

If the failure occurred during use in a patient, for an AE to be valid and investigated it must have 4 minimum data elements: identifiable patient, identifiable reporter, suspect drug/device, and suspect AE.  You don't have to have a sample, but you do need a batch number.  Performing a technical complaint if it wasn't used in a patient may be a different story depending on your quality system instruction.  

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Amanda Broughton
Spokane WA
United States
------------------------------

Original Message:
Sent: 21-Feb-2017 07:06
From: Anonymous Member
Subject: Complaint Investigation

This message was posted by a user wishing to remain anonymous

I am looking for some advice.  What steps would you take to investigate a complaint if the complaint sample is not available for investigation and the lot/serial number is unknown?  The complaint involved the failure of a component.  The customer ordered the replacement part and replaced it themselves.  Your thoughts are appreciated.

Original Message------

This message was posted by a user wishing to remain anonymous

I am looking for some advice.  What steps would you take to investigate a complaint if the complaint sample is not available for investigation and the lot/serial number is unknown?  The complaint involved the failure of a component.  The customer ordered the replacement part and replaced it themselves.  Your thoughts are appreciated.

I think David meant CFR 820.198 (not .189)
Michael

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Michael Murphy
Vice President
Akonni Biosystems, Inc.
Frederick MD
United States
------------------------------

Original Message:
Sent: 24-Feb-2017 11:14
From: David Lim
Subject: Complaint Investigation

Dear A:

What steps would you take to investigate a complaint if the complaint sample is not available for investigation and the lot/serial number is unknown?

Your firm should have a process to handle all complaints in a uniform and consistent manner under 21 CFR 820.189

There are 8 elements to document for an investigation of the complaint.  Also there are additional three (3) elements to meet/document if an event is reportable to the FDA.  

To meet these elements, you can document based on your information available (even if not available) with reasonable attempts (should be documented) to obtain such info.  

I would recommend you have a chance to watch my recorded seminar on complaint handling and MDR at 

https://www.globalcomplianceseminar.com/complaint-handling-medical-device-reporting-mdr-recorded-gcs14-100r/

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

Regulatory Doctor / Educational/Training Services 

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

I'm not a big fan of the MDR regulation, due to its references to an investigation not being necessary.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 01-Mar-2017 15:09
From: Michael Murphy
Subject: Complaint Investigation

I think David meant CFR 820.198 (not .189)
Michael

------------------------------
Michael Murphy
Vice President
Akonni Biosystems, Inc.
Frederick MD
United States
------------------------------

Original Message:
Sent: 24-Feb-2017 11:14
From: David Lim
Subject: Complaint Investigation

Dear A:

What steps would you take to investigate a complaint if the complaint sample is not available for investigation and the lot/serial number is unknown?

Your firm should have a process to handle all complaints in a uniform and consistent manner under 21 CFR 820.189

There are 8 elements to document for an investigation of the complaint.  Also there are additional three (3) elements to meet/document if an event is reportable to the FDA.  

To meet these elements, you can document based on your information available (even if not available) with reasonable attempts (should be documented) to obtain such info.  

I would recommend you have a chance to watch my recorded seminar on complaint handling and MDR at 

https://www.globalcomplianceseminar.com/complaint-handling-medical-device-reporting-mdr-recorded-gcs14-100r/

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

Regulatory Doctor / Educational/Training Services 

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

Sorry,  I meant 820.198.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 01-Mar-2017 15:36
From: Julie Omohundro
Subject: Complaint Investigation

I'm not a big fan of the MDR regulation, due to its references to an investigation not being necessary.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 01-Mar-2017 15:09
From: Michael Murphy
Subject: Complaint Investigation

I think David meant CFR 820.198 (not .189)
Michael

------------------------------
Michael Murphy
Vice President
Akonni Biosystems, Inc.
Frederick MD
United States
------------------------------

Original Message:
Sent: 24-Feb-2017 11:14
From: David Lim
Subject: Complaint Investigation

Dear A:

What steps would you take to investigate a complaint if the complaint sample is not available for investigation and the lot/serial number is unknown?

Your firm should have a process to handle all complaints in a uniform and consistent manner under 21 CFR 820.189

There are 8 elements to document for an investigation of the complaint.  Also there are additional three (3) elements to meet/document if an event is reportable to the FDA.  

To meet these elements, you can document based on your information available (even if not available) with reasonable attempts (should be documented) to obtain such info.  

I would recommend you have a chance to watch my recorded seminar on complaint handling and MDR at 

https://www.globalcomplianceseminar.com/complaint-handling-medical-device-reporting-mdr-recorded-gcs14-100r/

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

Regulatory Doctor / Educational/Training Services 

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.