COBAS AMPLIPREP / COBAS TAQMAN HCV, CE IVD

Description of Event or Problem

A CUSTOMER SITE IN (B)(6) ALLEGED (B)(6) RESULTS WERE GENERATED WITH THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) HCV TEST. SPECIFICALLY, THE CUSTOMER REPORTED THAT (B)(6) WAS GENERATED FOR ONE PATIENT SAMPLE USING THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) HCV TEST. THE SAME SAMPLE WAS THEN TESTED WITH BOTH THE ABBOTT M2000 ((B)(6)) AND WITH A REAL TIME PCR HOME BREW TEST ((B)(6)). GENOTYPING WAS ALSO PERFORMED (B)(6).

Additional Manufacturer Narrative

(B)(4): DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION: NO FAILURE DETECTED AND PRODUCT PERFORMED WITHIN SPECIFICATION. UNABLE TO CONFIRM COMPLAINT. NO PRODUCT OR BATCH NON-CONFORMANCE WAS IDENTIFIED. ANALYSIS OF THE GROWTH CURVE FOR THE SAMPLE DID NOT INDICATE ANY ANOMALIES THAT WOULD CONTRIBUTE TO THE UNDERQUANTITATION. UPON INVESTIGATION THERE WAS NO TREND FOUND IN THE FIELD. QC RELEASE DATA FOR 051681 WAS REVIEWED AND THE ISSUE OF UNDERQUANTITATED SAMPLES HAS NOT BEEN OBSERVED. THERE HAVE NOT BEEN ANY MANUFACTURING NON-CONFORMANCE REPORTS FOR BATCH 051681. NO SAMPLE MATERIAL WAS AVAILABLE FROM THE CUSTOMER FOR INVESTIGATIVE TESTING. (B)(4).

Additional Manufacturer Narrative

A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. (B)(4).