Dan said "I recommend that you file the MDR. I'm very conservative about these things. I've never seen a Warning Letter for submitting too many MDRs, but there are many for too few."
I used to feel this way as well, and at one time it was no doubt true - the biggest risk to MDR filing was your competitors would use them against you. However, having now been through two different situations of FDA using their "early signal detection process" in which the entire signal was "there seem to be a lot of MDRs," I have changed my thinking. In both these cases, the situation took years to resolve and the impact to the business was enormous, given that HOSPITALS think that FDA has actual facts when they send out notices, and in no way to they differentiate from "early signals" and "full blown safety notices."
Thus, while I am still a stickler for filing MDRs in situations where the definition is met, I am much less bullish on filing for complete grey areas (such as when I can think up a crazy scenario where an injury could occur but never has). I am not entirely sure we have enough info from the original poster to know if they need an MDR or not, but I totally agree it is one of the things that must be assessed as they work through the process.
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 06-Jul-2020 09:32
From: Dan O'Leary
Subject: Faulty calibration meter and adverse event
I infer you market your medical device is the US, so I've confined my response to that system. Other geographic regions could have different answer.
Under 820.72(b), "evaluate whether there was any adverse effect on the device's quality". You didn't describe the type of failure, but the most common problem is bias in the instrument's reading that causes you classify nonconforming product as conforming based on the measurement. This is the adverse effect.
If so, take two actions. Correction brings the instrument back into a functional state. Corrective action, determines the cause of the nonconformance and eliminates. Be sure to follow the corrective action process in 820.100.
Under 803.50(a)(2) file a medical device report, MDR, if the device malfunctioned and would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended. I think this situation meets the definition of a malfunction.
Be sure to create an MDR Event File under 803.18 and c complaint under 820.198. I often see people argue that a complaint requires a report from a customer, but this is not true. You can create a complaint based on internal actions as long as the device had been released for distribution.
I recommend that you file the MDR. I'm very conservative about these things. I've never seen a Warning Letter for submitting too many MDRs, but there are many for too few.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 04-Jul-2020 09:30
From: Anonymous Member
Subject: Faulty calibration meter and adverse event
This message was posted by a user wishing to remain anonymous
Hi,
Can you advise on the actions necessary if the calibration meter which was used for calibrating medical devices is found to be faulty . There was no injury caused but could have had the potential to cause one.