COBAS AMPLIPREP / COBAS TAQMAN HCV, CE IVD

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).

Additional Manufacturer Narrative

(B)(4). RESULT - NO FAILURE DETECTED. CONCLUSION - UNABLE TO CONFIRM COMPLAINT. THE SAMPLES WERE SENT BY THE CUSTOMER FOR INVESTIGATIVE TESTING. HOWEVER, THE SHIPMENT ARRIVED AND THE FROZEN PATIENT SAMPLES HAD THAWED. THEREFORE, INVESTIGATIVE TESTING COULD NOT BE PERFORMED, AS THE SAMPLE INTEGRITY HAD BEEN COMPROMISED. NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED, AS THE DISCREPANT RESULTS ALLEGED BY THE CUSTOMER WERE NOT OBSERVED IN THE SUPPLIED DATA. THE TARGET AND QS CT VALUES WERE CONSISTENT AND NOT REPRESENTATIVE OF ANY UNDERLYING ISSUE WITH AMPLIFICATION OR DETECTION. THE GROWTH CURVES APPEARED TYPICAL AND AS EXPECTED. ALL RUN CONTROLS WERE VALID. WHEN COMPARING THE CAP/CTM HCV TEST RESULTS FOR THIS PATIENT ( FROM (B)(6)-2011), THE TITERS PROGRESSIVELY DECREASED IN VALUE OVER TIME. ALTHOUGH UNKNOWN, THESE DIFFERENCES COULD BE INDICATIVE OF THE PATIENT RESPONDING TO TREATMENT. THE CUSTOMER AND AFFILIATE WERE UNABLE TO PROVIDE ANY INFORMATION ON THE PATIENT, INCLUDING TREATMENT REGIMEN. THE ISSUE APPEARS TO BE SPECIFIC TO SAMPLES COLLECTED FROM THIS PATIENT BASED ON THE DATA PROVIDED; THE CUSTOMER DID NOT INDICATE ANY OTHER ISSUES OF OVER-QUANTITATED TITERS FROM OTHER PATIENT SAMPLES TESTED WITH THE COMPLAINT KIT BATCH OR PRODUCT. THE CAP/CTM HCV PACKAGE INSERT DOES NOT CONTAIN METHOD CORRELATION STUDY COMPARISON DATA BETWEEN THE CAP/CTM HCV TEST AND THE ABBOTT M2000. THEREFORE, NO CONCLUSIONS CAN BE MADE REGARDING THE RESULT DISCREPANCIES REPORTED BETWEEN THE TWO TESTS. (B)(4).

Description of Event or Problem

A CUSTOMER SITE IN (B)(6) REPORTED THAT DISCREPANT RESULTS WERE GENERATED WITH THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) HCV TEST WHEN COMPARED WITH TEST RESULTS THAT WERE GENERATED WITH ABBOTT M2000 TEST. THE CUSTOMER STATED THAT A PATIENT WITH LIVER CANCER AND (B)(6) INFECTION WAS TESTED WITH THE CAP/CTM HCV TEST SEVERAL TIMES. INITIAL RESULTS OF (B)(6) WERE OBTAINED. THE PATIENT TESTING WAS REPEATED AT A LATER DATE WITH THE CAP/CTM HCV TEST (NONE OF THE ANALYSIS DATES WERE IDENTIFIED) WITH RESULTS OF (B)(6). IT IS NOT KNOWN IF THE LATER RESULTS WERE FROM A NEW COLLECTION OR THE ORIGINAL COLLECTION. THE SAME PATIENT WAS MONITORED IN A DIFFERENT LAB WITH THE ABBOTT M2000 TEST (ANALYSIS DATES AND COLLECTION INFORMATION UNKNOWN) AND RESULTS OF (B)(6) WERE OBTAINED.