D4.Medical device lot#: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H.6.Investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges discrepant result when using kit flu a+b 30 test hospital veritor (material # 256041), batch number unknown.It was reported that the customer visually detected a flu b + result and the analyzer gave a flu b+ result, however the line was faint and upon re-inserting the cartridge into the analyzer, it read as flu b- (negative).The customer mentioned that the second result (flu b-) was not reported, so no impact to the patient treatment.Bd quality performs a systematic approach to investigate all discrepant result complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Batch history record (bhr) review and retain sample testing could not be performed because the batch number was not provided.No photos or physical samples were returned; therefore, return sample analysis could not be performed.According to the report, the customer reinserted the test device into the analyzer.Bd representative advised the customer that this test is not designed to interpret the results visually and the results should only be read through analyzer, and also the same cartridge should not be reinserted.Suggested to repeat the test with a new test device, if any concerns on the results.The reported issue was unable to be confirmed.Currently, there are no adverse trends identified for discrepant result.H3 other text : see h.10.
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