COBAS TAQMAN HCV 48 V2.0 CE-IVD QUANT

Description of Event or Problem

A CUSTOMER FROM GREECE GENERATED DISCREPANT RESULTS WITH AN ACROMETRIX EXTERNAL CONTROL WHEN USING THE COBAS TAQMAN (CTM) (B)(6) TEST V.2.0 FOR USE WITH THE HIGH PURE SYSTEM COMPARED TO THE IN-HOUSE LIGHTCYCLER (LC) TEST. THE CTM (B)(6) V2.0 TEST GENERATED "TARGET NOT DETECTED" RESULTS. ONE OF THE SAMPLES, EXPECTED TO HAVE A TITER OF (B)(6), WAS TESTED WITH THE LC INHOUSE TEST AND GENERATED A RESULT OF (B)(6). THE OTHER TWO CONTROL SAMPLES GENERATED RESULTS OF (B)(6) WITH THE LC IN-HOUSE TEST. THE CTM (B)(6) V2.0 ROCHE KIT CONTROLS WERE VALID. IT IS NOT YET KNOWN, IF PATIENT RESULTS WERE INVOLVED.

Additional Manufacturer Narrative

THE INVESTIGATION INTO THIS REPORTED ISSUE IS ONGOING, AND THEREFORE, NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE CONCLUSION OF THIS INVESTIGATION WILL BE REPORTED THROUGH A FOLLOW-UP REPORT. (B)(4).

Additional Manufacturer Narrative

DEVICE EVALUATED BY MANUFACTURER: YES. RESULTS: DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION: NO FAILURE DETECTED AND PRODUCT PERFORMED WITHIN SPECIFICATION. NO PRODUCT OR BATCH NON-CONFORMANCE WAS IDENTIFIED. UPON INVESTIGATION, THERE WAS NO TREND FOUND IN THE FIELD. QC RELEASE DATA FOR 058118 WAS REVIEWED AND THE ISSUE OF DISCREPANT RESULTS HAS NOT BEEN OBSERVED. THERE HAVE NOT BEEN ANY MANUFACTURING NON-CONFORMANCE REPORTS FOR BATCH 058118. RETAIN TESTING OF THE COMPLAINT BATCH 058118 WAS PERFORMED ACCORDING TO KIT RELEASE PROCEDURES. ALL RESULTS WERE WITHIN SPECIFICATIONS; TESTING DID NOT REPRODUCE THE ALLEGATION. THE CUSTOMER REQUESTED SEQUENCING FOR THE AVAILABLE EXTERNAL CONTROLS. SAMPLES 128620 AND 128623 WERE SEQUENCED AND GENERATED THE FOLLOWING RESULTS: THERE WERE NO MISMATCHES PRESENT AT ANY OF THE (B)(4) FOR SAMPLES 128620 AND 128623, WHICH COULD IMPACT RESULTS. - SAMPLES 128620 AND 128623 WERE DETERMINED TO BE (B)(6). NO OTHER INFORMATION OR DATA REGARDING THE EXTERNAL CONTROLS WAS MADE AVAILABLE. (B)(4).