BD PROBETEC¿ NEISSERIA GONORRHOEAE (GC) QX ASSAY GRAY AMP REAGENT PACK

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD PROBETEC¿ NEISSERIA GONORRHOEAE (GC) QX ASSAY GRAY AMP REAGENT PACK PATIENT SAMPLE TESTED POSITIVE FOR GC HOWEVER WHEN RETESTED PATIENT WAS GC NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS ONE PATIENT SAMPLE WITH A DISCREPANT GC RESULT WHILE USING CAT 442842 LOT 2348937. PER CUSTOMER, A CT/GC SPECIMEN WAS TESTED ON (B)(6) 2023 AND IT WAS POSITIVE FOR GC. PROVIDED CALLED CUSTOMER ON (B)(6) 2023 ASKING FOR SPECIMEN TO BE REPEATED AS PATIENT SHOULD NOT BE POSITIVE. PATIENT HAD TESTING DONE AT ANOTHER FACILITY AND GC RESULT WAS NEGATIVE. CUSTOMER COULD NOT PROVIDE THE NAME OF THE OTHER FACILITY OR THE INSTRUMENTATION/METHODOLOGY USED. LAST CT/GC EM WERE PERFORMED ON (B)(6) 2023. CUSTOMER ALTERNATES EVERY OTHER MONTH WITH HPV. CT/GC ONLY PERFORMED ONCE A WEEK. CUSTOMER WILL REPEAT THE SPECIMEN ON (B)(6) 2023 WITH THE REST OF THE NEW SPECIMENS AND EM. PER CUSTOMER, THE SPECIMEN HAD A VERY LOW VALUE IN THE REPORT. FOLLOW UP EMAIL SENT TO CUSTOMER REQUESTING RESULT PRINT OUT. IF YES, DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): GC RESULT WAS REPORTED AS POSITIVE. PATIENT QUESTIONED THE RESULTS AND A NEW TEST WAS PERFORMED AT A DIFFERENT FACILITY AND THE RESULT WAS NEGATIVE. PROVIDED CONTACTED CUSTOMER TO REPEAT TESTING FROM ORIGINAL SAMPLE. PATIENT HAS NOT BEEN TREATED.

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD PROBETEC¿ NEISSERIA GONORRHOEAE (GC) QX ASSAY GRAY AMP REAGENT PACK PATIENT SAMPLE TESTED POSITIVE FOR GC HOWEVER WHEN RETESTED PATIENT WAS GC NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS ONE PATIENT SAMPLE WITH A DISCREPANT GC RESULT WHILE USING CAT 442842 LOT 2348937. PER CUSTOMER, A CT/GC SPECIMEN WAS TESTED ON (B)(6) 2023 AND IT WAS POSITIVE FOR GC. PROVIDED CALLED CUSTOMER ON (B)(6) 2023 ASKING FOR SPECIMEN TO BE REPEATED AS PATIENT SHOULD NOT BE POSITIVE. PATIENT HAD TESTING DONE AT ANOTHER FACILITY AND GC RESULT WAS NEGATIVE. CUSTOMER COULD NOT PROVIDE THE NAME OF THE OTHER FACILITY OR THE INSTRUMENTATION/METHODOLOGY USED. LAST CT/GC EM WERE PERFORMED ON (B)(6) 2023. CUSTOMER ALTERNATES EVERY OTHER MONTH WITH HPV. CT/GC ONLY PERFORMED ONCE A WEEK. CUSTOMER WILL REPEAT THE SPECIMEN ON (B)(6) 2023 WITH THE REST OF THE NEW SPECIMENS AND EM. PER CUSTOMER, THE SPECIMEN HAD A VERY LOW VALUE IN THE REPORT. FOLLOW UP EMAIL SENT TO CUSTOMER REQUESTING RESULT PRINT OUT. IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): GC RESULT WAS REPORTED AS POSITIVE. PATIENT QUESTIONED THE RESULTS AND A NEW TEST WAS PERFORMED AT A DIFFERENT FACILITY AND THE RESULT WAS NEGATIVE. PROVIDED CONTACTED CUSTOMER TO REPEAT TESTING FROM ORIGINAL SAMPLE. PATIENT HAS NOT BEEN TREATED.

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: BD INTEGRATED DIAGNOSTIC SYSTEMS INITIATED AN INVESTIGATION INTO DISCREPANT RESULTS ON THE CTQX/GCQX ASSAY ON THE BD VIPER LT SYSTEM (CATALOG # 442842, BATCH # 2348937). BD INVESTIGATION REQUIRED REVIEW OF THE BATCH HISTORY RECORDS, FUNCTIONAL ANALYSIS ON CUSTOMERS REPORTED REAGENT BATCHES AND COMPLAINT TRENDING REVIEW. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. FUNCTIONAL ANALYSIS ON THE CUSTOMERS REPORTED REAGENT BATCHES WERE PERFORMED AND THE RESULTS MET ACCEPTANCE CRITERIA. WE WERE UNABLE TO CONFIRM THE CUSTOMERS COMPLAINTS. THERE ARE NO CURRENT TRENDS ASSOCIATED WITH DISCREPANT RESULTS ON THE CTQX/GCQX ASSAY ON THE BD VIPER LT SYSTEM. BD APOLOGIZES FOR ANY INCONVENIENCE. IF THERE ARE ANY QUESTIONS OR CONCERNED, PLEASE SO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.