COBAS TAQSCREEN MPX TEST, V2.0, CE-IVD

Additional Manufacturer Narrative

THE INVESTIGATION INTO THIS ISSUE IS CURRENTLY ON-GOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. THE UDI FOR THE COBAS TAQSCREEN MPX TEST, V2.0, CE-IVD IS (B)(4). THE CORRESPONDING US KIT MATERIAL NUMBER IS (B)(4).

Description of Event or Problem

A (B)(6) CUSTOMER INDICATED THAT 3 DONORS WERE REPEATEDLY GENERATING (B)(6) SEROLOGY RESULTS WITH MULTIPLE SEROLOGY TESTS AND (B)(6) PCR RESULTS WITH THE COBAS TAQSCREEN MPX TEST, V2.0, CE-IVD FOR USE ON THE COBAS S 201 SYSTEM. AS MULTIPLE COBAS TAQSCREEN MPX TEST, V2.0 KIT LOTS WERE USED AND GENERATED CONSISTENT RESULTS, THIS MDR IS NOT SPECIFIC TO ANY LOT; RATHER, IT IS SPECIFIC FOR THE PRODUCT IN GENERAL. THIS MDR REPORT (2243471-2016-00004) IS SPECIFIC TO DONOR #1.

Additional Manufacturer Narrative

A (B)(6) CUSTOMER INDICATED THAT 3 DONORS WERE REPEATEDLY GENERATING (B)(6) RESULTS WITH MULTIPLE SEROLOGY TESTS AND (B)(6) RESULTS WITH THE COBAS TAQSCREEN MPX TEST, V2.0, CE-IVD FOR USE ON THE COBAS S 201 SYSTEM. AS MULTIPLE COBAS TAQSCREEN MPX TEST, V2.0 KIT LOTS WERE USED AND GENERATED CONSISTENT RESULTS, THIS MDR IS NOT SPECIFIC TO ANY LOT; RATHER, IT IS SPECIFIC FOR THE PRODUCT IN GENERAL. THIS MDR REPORT (2243471-2016-00004) IS SPECIFIC TO DONOR #1. ON (B)(6)-2015, A NEW DRAW WAS OBTAINED FROM THE DONOR AND RUN IN PP1 WITH COBAS TAQSCREEN MPX TEST, V2.0 KIT, LOT 193607 WHICH AGAIN GENERATED A (B)(6) RESULT. THESE RESULTS ARE IN AGREEMENT WITH THE PREVIOUS ORIGINAL (B)(6) RESULTS. THE DONATION WAS ADDITIONALLY TESTED IN (B)(6) USING THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) HCV QUANTITATIVE TEST, V2.0 BATCH 173806 AND GENERATED (B)(6) RESULTS. THIS FURTHER RULES OUT MUTATIONS IN THE TARGET REGION OF THE MPX V2 TEST, AS THE CAUSE OF THE (B)(6) RESULTS, AS THE CAP/CTM HCV V2 TEST IS DUAL PROBE AND GENERATED A (B)(6) RESULT. BASED ON THE DATA PROVIDED AND INPUT FROM ROCHE MEDICAL AND SCIENTIFIC AFFAIRS GROUP, THE COMPLAINT ISSUE IS LIKELY DUE TO PATIENTS WHO ARE ABLE TO CLEAR THEIR (B)(6) INFECTION, HOWEVER, MAY REMAIN (B)(6). SCIENTIFIC LITERATURE ON THE SUBJECT STATES THAT ABOUT 20% OF PEOPLE CLEAR THE INFECTION (BUT REMAIN ANTIBODY POSITIVE) AND, IN DONORS, THE PERCENTAGE THAT ARE RNA NEGATIVE SEEMS TO BE HIGHER. RETAIN TESTING OF THE COMPLAINT KIT BATCHES 193607 AND 185527 MET SPECIFICATIONS AND DID NOT REPRODUCE THE CUSTOMER ALLEGATION. BASED ON THIS INFORMATION, THERE IS NO INDICATION OF A PRODUCT NON-CONFORMANCE AND THE COBAS TAQSCREEN MPX TEST, V2.0 IS PERFORMING AS INTENDED. (B)(4).