Investigation conclusion: the customers complaint was not replicated during in-house testing of retain lot w63726rb with whole blood donors and in-house samples.Testing found no issues with product performance; no discordant ckmb results were observed.Manufacturing batch records for lot w63726rb were reviewed and found that the lot met final release specifications.No issues with ckmb recovery observed.The device was not returned for evaluation; however, patient sample was returned.Observed elevated ckmb results with the returned patient sample.Hama interference testing was inconclusive.The returned patient sample was observed to be severely hemolyzed.Although hama interference testing was inconclusive, additional sample specific factors/interference in the returned sample cannot be ruled out as the cause of the complaint.Based on the information available, there is no indication of a product deficiency and no corrective action is required.This event is related to mdr 3013982035-2018-00010.
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