COBAS AMPLICOR CHLAMYDIA TACHOMATIS TEST

Description of Event or Problem

A CUSTOMER SITE IN THE UNITED STATES HAS ALLEGED THAT THEY HAD TWO SAMPLES THAT GENERATED (B)(6) RESULTS; HOWEVER; WHEN REDETECTED GENERATED (B)(6) RESULTS (BEING REPORTED THROUGH MDR 2243471-2011-00083 AND -00084) WITH THE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST. SPECIFICALLY, THE CUSTOMER INDICATED THAT THEY HAD TWO RECENT RUNS WITHIN A TWO WEEK TIME FRAME WHERE A SAMPLE THAT WAS (B)(6) WAS REDETECTED AND GENERATED (B)(6) RESULTS WITH THE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST. THE CUSTOMER INDICATED THAT THE SAMPLES WERE REDETECTED DUE TO A HARDWARE ERROR THAT OCCURRED MID-RUN. NOTE: RE-AMPLIFICATION AND RE-DETECTION OF A SAMPLE WITH THE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST IS OFF-LABEL PRACTICE.

Additional Manufacturer Narrative

(B)(4): METHOD: ANALYSIS OF LABELING AND (REVIEW OF TREND DATA AND ANALYSIS OF RAW DATA FROM THE CUSTOMER SITE). RESULT: DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION : NO FAILURE DETECTED AND PRODUCT PERFORMED WITHIN SPECIFICATION. NO PRODUCT OR BATCH NON-CONFORMANCE WAS IDENTIFIED. ANALYSIS OF THE RAW DATA SHOWS, THAT THE PATIENT WAS SYMPTOMATIC, AND THE NEGATIVE CT RESULT IS CONSIDERED TO BE A FALSE (B)(6) RESULT. UPON INVESTIGATION THERE WAS NO TREND FOUND IN THE FIELD. QC RELEASE DATA FOR THE KIT BATCHES MET SPECIFICATIONS. KIT BATCH N18071 GENERATED ACCEPTABLE RESULTS DURING STABILITY TESTING. AS PER THE METHOD MANUAL, THE SENSITIVITY OF THE TEST IS NOT 100% WHEN ON-LABEL SAMPLE TYPES ARE TESTED. AS NO STATISTICS (POSITIVE PREDICATIVE VALUES, NEGATIVE PREDICTIVE VALUES, FALSE POSITIVE RATES, FALSE NEGATIVE RATES, AND THE NUMBER OF SAMPLES TESTED IN A GIVEN YEAR) WERE PROVIDED THROUGH THE CURRENT CASE, NO FURTHER ANALYSIS COULD BE PERFORMED TO DETERMINE IF THE FALSE NEGATIVE RESULT FALLS WITHIN THE CLAIMS OF THE TEST. AS STATED IN THE COBAS AMPLICOR CT/NG FOR CT METHOD MANUAL, VERIFICATION OF CT ANTIGEN OR NUCLEIC ACID WITH AN ALTERNATE METHOD IS RECOMMENDED BY THE CDC. ALTHOUGH REQUESTED, NO PATIENT SAMPLES WERE PROVIDED BY THE CUSTOMER FOR FURTHER INVESTIGATIVE TESTING. (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).