Any complaint that implicates a device potentially not meeting its expected specifications or attributes in my opinion needs to be investigated to determine if the device, in fact, did not meets its specifications. Only way to do that is to determine whether or not the device
might be out of specification. In other words, could the complaint indicate that something in the device did not function properly as expected. If it is possible then a more detailed deep-dive review needs to happen. Just because something is "warned of" in the documentation doesn't, in my opinion, completely exonerate the company from determining whether or not the device truly failed in some respect because if the device failed and if you are seeing a trend in failures of the device there is the potential that while the defect is warned of in the labeling or IFU the defect, if happening at a high rate, could easily change the benefit-risk ratio calculus.
In your example, if the device were to have the issues you note, would that delay therapy or could that be something that would prompt additional medical attention or would the physician or patient be unable to perform a potentially necessary review of the data needed for proper treatment? In any of these situations I would consider this a device failure that would need to be reviewed. Has this issue been at 50% even when you were testing the device? If it was only 20% of the time during testing and now 50% of your issues appear to be for this reason - something else very well could be impacting the device that needs to be understood and potentially rectified. I truly don't think I look at "device failure" or "device feature failure" any differently. If the device is meant to have a particular attribute and the device fails to perform according to that attribute, the device failed...feature or not, nice to have or essential, really shouldn't make any difference in the calculation of next steps in my opinion. It might make a difference in the severity of the issue, but it is still an issue.
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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 09-Feb-2019 23:36
From: Rashmi Pillay
Subject: Complaints again - 'Possible failure'
Hi
As per 21 CFR 820.198 "(c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary."
How do you determine it's a 'possible failure' , do you need to check the complaint against the device PRS/SRS ? For example 50% of our complaints involve device error states whereby it reverts to standby and the modules needing to be replaced. There's a debate whether this is considered as failure of the device or a device feature . Or do you need to consider the device reliability to determine the failure ?
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
W ellex.com
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