ALINITY M STI AMPLIFICATION REAGENT KIT

Additional Manufacturer Narrative

A1, B5, D4 (LOT NUMBER, EXPIRATION DATE, AND UDI), AND H4 UPDATED WITH ADDITIONAL INFORMATION.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED ON 08/07/2023. THE CUSTOMER REPORTED THAT THE SAMPLE ID (SID) WAS (B)(6) (TESTED ON ALINITY ON (B)(6) 2023) AND (B)(6) R (TESTED ON ALINITY ON (B)(6) 2023). THE SAMPLE TYPE WAS MALE RECTAL SWAB. THE SAMPLES WERE RETESTED ON INGENIOUS ON (B)(6) 2023 AND (B)(6) 2023. THE CT NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER REPORTED THAT GONORRHEA SAMPLES ARE TESTED ON DIFFERENT PLATFORM FOR CONFIRMATION OF THE RESULTS. INGENIOUS (B)(6) 2023 CHLAMYDIA POS CYCLE THRESHOLD (CT)=26.88 GONORRHOEA POS CT=24.51. INGENIOUS (B)(6) 2023 CHLAMYDIA POS CT=26.68 GONORRHOEA POS CT=24.26. ALINITY ELSA (B)(6) 2023 CHLAMYDIA NEG GONORRHOEA POS CT=21.27. ALINITY ELSA (B)(6) 2023 CHLAMYDIA NEG GONORRHOEA POS CT=20.94. TECHNICAL APPLICATION SPECIALIST (TAS) DOWNLOADED LOG FILE VIA ABBOTTLINK FOR ANALYSIS. LOG FILE ANALYSIS REVEALED THAT ON 07/04/2023 THE CUSTOMER RAN THE SAMPLE AS SID (B)(6) ON ALINITY M, THE SAMPLE FAILED FOR ALL THE TARGETS EXCEPT NG, DUE TO INTERNAL CONTROL FAILURE AND CELLULAR CONTROL FAILURE. ON THE (B)(6) 2023, THE SAMPLE WAS RUN WITH SID (B)(6) R AND AGAIN ONLY NG PASSED (WHICH WAS POSITIVE WITH A FLAG "FAILED CONTROL"). THE INTERNAL CONTROL FAILED. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING "ALINITY ELSA". BASED ON THE INFORMATION PROVIDED AT THIS TIME, THE CUSTOMER IS REPORTING DISCREPANT RESULTS ON THE ALINITY M INSTRUMENT.

Additional Manufacturer Narrative

CORRECTION TO H10: CORRECT RETAIN / FILE SAMPLE EVALUATION AND CUSTOMER DATA REVIEW SECTIONS: RETAIN / FILE SAMPLE EVALUATION: THE FILE SAMPLE EVALUATION FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 381561 WAS PERFORMED. THE EVALUATION WAS PERFORMED TO DETERMINE IF A PRODUCT DEFICIENCY COULD BE IDENTIFIED FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 381561 REGARDING FALSE NEGATIVE RESULTS. ALL CALIBRATOR AND CONTROLS PASSED WITHOUT ANY ERROR CODES (EC) AND WERE INTERPRETED CORRECTLY BY THE ASSAY SOFTWARE. THE NEGATIVE SAMPLES THAT WERE TESTED PASSED WITHOUT ANY ECS AND WERE INTERPRETED CORRECTLY BY THE ASSAY SOFTWARE. MOREOVER, THERE WERE NO INSTANCES OF FALSE NEGATIVE SAMPLES; THEREFORE, THE FILE SAMPLE EVALUATION FOR LOT 381561 MET THE ACCEPTANCE AND VALIDITY CRITERIA. FILE SAMPLE TESTING FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 381561 RECEIVED A DISPOSITION OF PASSED WITH A 100% SPECIFICITY FOR THE TEST. CUSTOMER DATA REVIEW: THE VALIDITY OF THE RUNS CONTAINING THE DISCREPANT RESULTS WERE VERIFIED. THE ASSAY MET SPECIFICATION REQUIREMENTS AND NO ERROR CODES AND FLAGS WERE DISPLAYED FOR THE RUN CONTROLS. THERE IS NO INDICATION THAT THE ALINITY M STI AMP KIT (LIST 09N17-091) LOT 381561 IS PERFORMING OUTSIDE OF ESTABLISHED DESIGN PERFORMANCE SPECIFICATIONS. THE DISCREPANT RESULTS WERE ANALYZED. FOR THE CT TARGET, NO RESULT WAS REPORTED ON THE ALINITY M AND A MESSAGE CODE WAS GENERATED AS THE INTERNAL CONTROL (IC) AND CELLULAR CONTROL (CC) CYCLE NUMBERS WERE OUT OF RANGE. THE NG TARGET WAS DETECTED AND ADDITIONALLY FLAGGED FOR IC AND CC FAILURES. FLAGS PROVIDE ADDITIONAL INFORMATION ABOUT A RESULT AND INDICATE THAT THE RESULT MAY NEED TO BE REVIEWED. FOR POSITIVE SPECIMENS: IF THE IC CN OR CC CN IS OUT OF RANGE, BUT THE ANALYTE(S) IN THAT SAMPLE IS POSITIVE, THE SAMPLE WILL YIELD A POSITIVE RESULT. AN IC FLAG OR CC FLAG WILL BE REPORTED NEXT TO THE POSITIVE RESULT. FOR NEGATIVE SPECIMENS: IF THE IC CN OR CC CN IS OUT OF RANGE AND THE ANALYTE(S) IN THAT SAMPLE IS NOT POSITIVE, NO RESULT WILL BE REPORTED FOR THE ANALYTE(S) AND A MESSAGE CODE WILL BE GENERATED.

Additional Manufacturer Narrative

INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, QUALITY DATA REVIEW, AND A COMPLAINT HISTORY REVIEW. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: RETAIN / FILE SAMPLE EVALUATION: THE FILE SAMPLE EVALUATION FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 381561 WAS PERFORMED. THE EVALUATION WAS PERFORMED TO DETERMINE IF A PRODUCT DEFICIENCY COULD BE IDENTIFIED FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 381561 REGARDING FALSE POSITIVE RESULTS. ALL CALIBRATOR AND CONTROLS PASSED WITHOUT ANY ERROR CODES (EC) AND WERE INTERPRETED CORRECTLY BY THE ASSAY SOFTWARE. THE NEGATIVE SAMPLES THAT WERE TESTED PASSED WITHOUT ANY ECS AND WERE INTERPRETED CORRECTLY BY THE ASSAY SOFTWARE. MOREOVER, THERE WERE NO INSTANCES OF FALSE POSITIVE SAMPLES; THEREFORE, THE FILE SAMPLE EVALUATION FOR LOT 381561 MET THE ACCEPTANCE AND VALIDITY CRITERIA. FILE SAMPLE TESTING FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 381561 RECEIVED A DISPOSITION OF PASSED WITH A 100% SPECIFICITY FOR THE TEST. CUSTOMER DATA REVIEW: THE VALIDITY OF THE RUNS CONTAINING THE DISCREPANT RESULTS WERE VERIFIED. THE ASSAY MET SPECIFICATION REQUIREMENTS AND NO ERROR CODES AND FLAGS WERE DISPLAYED FOR THE RUN CONTROLS. THE AMPLIFICATION CURVES APPEAR NORMAL AND EXHIBITED NORMAL AMPLIFICATION FOR THE CT/NG TARGETS, AS WELL AS FOR THE INTERNAL CONTROL. THE ASSAY IS PERFORMING AS EXPECTED WITH CORRECT INTERPRETATIONS. QUALITY DATA REVIEW: DEVICE HISTORY RECORD / BATCH RECORD REVIEW THE MANUFACTURING PACKET FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 381561 (INCLUDING COMPONENT LOT NUMBERS 780377 AND 780584) WERE REVIEWED TO IDENTIFY IF THERE WERE ANY ISSUES RELATED TO THE REPORTED COMPLAINT. REVIEW OF THE MANUFACTURING PACKETS FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 381561 (INCLUDING ITS COMPONENTS) DID NOT IDENTIFY ANY ISSUES WHICH COULD RESULT IN THE REPORTED COMPLAINT. NO RECORDS RELATED TO THE REPORTED COMPLAINT WERE FOUND THAT WOULD INDICATE ANY ISSUES WHICH COULD HAVE LED TO THE REPORTED COMPLAINT. ADDITIONALLY, THE QUALITY CONTROL (QC) AMP KIT MASTERLOT TESTING FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 381561 (INCLUDING COMPONENTS) MET ALL VALIDITY AND ACCEPTANCE CRITERIA. NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED DURING QC TESTING. CAPA / NON-CONFORMANCE REVIEW: A CAPA LOT SEARCH WAS PERFORMED TO IDENTIFY ANY EXISTING INTERNAL QUALITY RECORDS WHICH COULD RESULT IN THE REPORTED COMPLAINT DURING PRODUCTION OR INTERNAL USE. THE LOT NUMBERS 381561 (KIT LOT), 780377, AND 780584 (COMPONENT LOTS) WERE SEARCHED. THIS CAPA REVIEW FOR LOTS 381561, 780377 AND 780584 DID NOT IDENTIFY ANY NONCONFORMANCES AND/OR INTERNAL PRODUCTION ISSUES WHICH COULD HAVE LED TO THE REPORTED COMPLAINT. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED AS A RESULT OF THIS REVIEW. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY REVIEW DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS RELATED TO KIT LOT NUMBER 381561. COMPLAINT TRENDING DID NOT IDENTIFY A TREND VIOLATION, AND THE UPPER CONTROL LIMIT WAS NOT EXCEEDED FOR PRODUCT 09N17 (TRENDING PART NUMBER). A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 381561 WAS NOT IDENTIFIED.

Additional Manufacturer Narrative

CORRECTED D2 FROM LSL TO QEP.

Additional Manufacturer Narrative

ELEVATED COMPLAINT INVESTIGATION WILL BE INITIATED. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN UNITED KINGDOM USING THE ALINITY M STI ASSAY, LIST NUMBER 9N17-91, WHICH IS THE SAME/ SIMILAR TO THE ALINITY M STI ASSAY, LIST NUMBER 9N17-95, WHICH RECEIVED FDA APPROVAL.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT ON THE ALINITY M STI AMP KIT. THE CUSTOMER SPECIFIED THAT A SAMPLE WHICH IS REPEATEDLY NEGATIVE ON FOR THE CHLAMYDIA TRACHOMATIS (CT) TARGET AND POSITIVE FOR NEISSERIA GONORRHOEAE (NG). THE CUSTOMER RE-RESTED THE SAMPLE ON ANOTHER ANALYZER (INGENIUS), THE SAMPLE WAS ALSO POSITIVE FOR CT. THE CUSTOMER REPEATED THE SAMPLE ON BOTH ALINITY M SYSTEM AND INGENIUS (ALTERNATIVE PLATFORM), BUT THE RESULT REMAINED THE SAME. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT. THE CUSTOMER DID NOT PROVIDE ADDITIONAL INFORMATION REGARDING WHY THE SAMPLE WAS RETESTED AND WHAT RESULT WAS REPORTED OUTSIDE OF THE LAB. AT THE TIME OF THIS REPORT, THE CUSTOMER IS OUT OF OFFICE UNTIL (B)(6) 2023. THEREFORE, THIS EVENT WILL BE RUN AS WORST CASE SCENARIO FALSE NEGATIVE ON THE ALINITY M STI AMP KIT.