KIT CAP-G/CTM HCV 48 TESTS VERSION 2

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).

Description of Event or Problem

A CUSTOMER SITE IN (B)(6) FILED A COMPLAINT ALLEGING THAT DISCREPANT RESULTS FOR TWO PATIENT SAMPLES WERE GENERATED WHILE EVALUATING A CORRELATION BETWEEN COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) HCV V1.0 AND V2.0 TESTS. THE RESULTS OF VERSION 1.0 WERE REPORTED TO THE PHYSICIAN. IT WAS STATED THAT NO ADVERSE EVENT WAS REPORTED AND NO PATIENT INFORMATION OR TREATMENT INFORMATION IS AVAILABLE. THIS REPORT WILL ADDRESS SPECIMEN 2 WITH CAP/CTM HCV V2.0. MDR 2243471-2013-00032 WILL ADDRESS SPECIMEN 2 WITH CAP/CTM HCV V1.0. MDR 2243471-2013-00030 AND 31 WILL ADDRESS SPECIMEN 1 RESULTS.

Additional Manufacturer Narrative

(B)(4). SPECIMEN 2 GENERATED RESULTS WITH THE CAP/CTM HCV V1.0 TEST OF 2.3 AND 2.0 LOG IU/ML VS. A RESULT OF 4.74 IU/ML WITH THE CAP/CTM HCV V2.0 TEST. FOR THE CAP/CTM HCV V2.0 TEST, THERE ARE MISMATCHES TO THE UPSTREAM PRIMER AT THE 5' END OF THE PRIMER AND ONE MISMATCH IN THE MIDDLE OF ONE OF THE TWO PROBES. THERE ARE MISMATCHES TO ONE OF TWO DOWNSTREAM PRIMERS THAT COULD AFFECT THE PRIMER'S PERFORMANCE. HOWEVER, THIS ASSAY HAS 2 DOWNSTREAM PRIMERS AND THERE ARE NO MISMATCHES TO THE SECOND PRIMER. THEREFORE, THESE ARE NOT EXPECTED TO AFFECT THE HCV V 2.0 PERFORMANCE. RETAIN KIT TESTING MET SPECIFICATIONS. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. (B)(4).