KIT CAP-G/CTM HCV 48 TESTS VERSION 1

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 (B)(6) 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 (B)(6) V1.0. MDR 2243471-2013-00033 WILL ADDRESS SPECIMEN 2 WITH (B)(6). MDR 2243471-2013-00030 AND 31 WILL ADDRESS SPECIMEN 1 RESULTS.

Additional Manufacturer Narrative

DATE OF REPORT 1/9/2014. DATE RECEIVED BY MANUFACTURER 1/9/2014. FOLLOW UP REPORT 1. DEVICE EVALUATED BY MANUFACTURER YES. (B)(4). SPECIMEN 2 GENERATED RESULTS WITH THE (B)(6) OF (B)(6) VS. A RESULT OF (B)(6) WITH THE (B)(6). SPECIMEN 2 WAS DETERMINED TO BE (B)(6) GENOTYPE 6. THE RESULTS OF THE SEQUENCING ANALYSIS FOR SPECIMEN 2 DETERMINED THAT THERE IS ONE MISMATCH IN THE DOWNSTREAM PRIMER NEAR THE 3' END IN THE CAP/CTM (B)(6) WHICH COULD AFFECT THE TEST'S PERFORMANCE AND EXPLAIN THE LOWER (B)(4) TITER GENERATED. WITH THE CAP/CTM (B)(6). AS STATED IN THE PROCEDURAL LIMITATIONS SECTION OF THE CAP/CTM (B)(6) PACKAGE INSERT, "THOUGH RARE, MUTATIONS IN THE HIGHLY CONSERVED REGIONS OF THE VIRAL GENOME COVERED BY THE COBAS AMPLIPREP / COBAS TAQMAN TEST PRIMERS AND/OR PROBE MAY RESULT IN THE UNDERQUANTITATION OF OR FAILURE TO DETECT THE PRESENCE OF THE VIRUS IN THIS CIRCUMSTANCE." RETAIN KIT TESTING MET SPECIFICATIONS. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. (B)(4).