COBAS AMPLICOR CT/NG TEST

Additional Manufacturer Narrative

CORRECTED DATA: DATE OF REPORT, DATE RECEIVED BY MANUFACTURER, FOLLOW-UP REPORT 1, ADDITIONAL INFORMATION, DEVICE EVALUATED BY MANUFACTURE: NO (THE PATIENT SAMPLE, KIT BATCH, AND CUSTOMER DATA WERE NOT PROVIDED), (B)(4): ANALYSIS OF LABELING PERFORMED. (B)(4): DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. (B)(4): UNABLE TO CONFIRM COMPLAINT, DEVICE OPERATED ACCORDING TO SPECIFICATIONS, DEVICE NOT RETURNED. DESPITE REPEATED ATTEMPTS, SUFFICIENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER TO PERFORM A MORE IN-DEPTH INVESTIGATION. THE DATE OF REPORT WAS SET BASED ON THE LAST DAY THE COMPLAINT CASE WAS OPEN, WHICH SIGNIFIED THE FINAL POINT WHERE NO NEW / ADDITIONAL INFORMATION WOULD BE PROVIDED. BASED ON THE AVAILABLE, MINIMAL INFORMATION, THE INVESTIGATION SHOWED NO EVIDENCE OF A PRODUCT NON-CONFORMANCE. THE SAMPLE IN QUESTION WAS NOT AVAILABLE FROM THE CUSTOMER FOR INVESTIGATIVE TESTING. THE ISSUE OF (B)(6) RESULTS WITH THE COBAS AMPLICOR TEST IS PLAUSIBLE AND MAY BE WITHIN METHOD MANUAL CLAIMS, HOWEVER NO INFORMATION WAS PROVIDED SUCH AS (B)(6) OR NUMBER OF SAMPLES TESTED TO DETERMINE IF THE RESULTS WERE WITHIN CLAIMS. THE SENSITIVITY / SPECIFICITY RATES, OUTLINED IN THE METHOD MANUAL, ARE ON AVERAGE BETWEEN 91.7-93.1% FOR SENSITIVITY AND 94.7 -97.9% FOR SPECIFICITY. THESE RATES ARE DEPENDENT ON SEX AND WHETHER AN INTERNAL CONTROL WAS USED. FURTHERMORE, IT IS UNKNOWN IF THE SAMPLE WAS TRULY (B)(6) INFECTION. BASED ON THE TEST RESULTS PROVIDED, INITIAL RESULT (B)(6) FOLLOWED BY DUPLICATE REPEAT TESTING THAT YIELDED TWO (B)(6) RESULTS, THIS ISSUE APPEARS TO BE ASSOCIATED WITH A (B)(6) RESULT. HOWEVER, WITHOUT FURTHER CLARIFICATION FROM THE CUSTOMER, OR THE PATIENT SPECIMEN, THIS HYPOTHESIS CANNOT BE CONFIRMED. (B)(4).

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 UNITED STATES REPORTED THAT THEY RECEIVED DISCREPANT (B)(6) RESULTS WHEN USING THE COBAS AMPLICOR CT/NG TEST. THE CUSTOMER SITE PROTOCOL IS TO REPEAT TEST ALL (B)(6) RESULTS IN DUPLICATE, WHICH IS AN OFF-LABEL PRACTICE. AS PER PRODUCT LABELING, A VALID RESULT SHOULD BE REPORTED. ROCHE DOES NOT RECOMMEND OR SUPPORT THE REPEATING OF VALID (B)(6) RESULTS FOR THE ASSAY. THE CUSTOMER SITE HAS BEEN REPORTING OUT THE REPEAT RESULTS WHEN THEY ARE IN AGREEMENT WITH THE INITIAL RESULT. THE ORIGINAL RESULT WAS (B)(6) AND THE BOTH REPEAT RESULTS WERE (B)(6). IT IS UNKNOWN WHICH RESULT WAS REPORTED.