ALINITY M STI AMP KIT

Additional Manufacturer Narrative

AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED INTERNATIONALLY USING THE ALINITY M STI ASSAY, LIST NUMBER 09N17-091, WHICH IS THE SAME/ SIMILAR TO THE ALINITY M STI ASSAY, LIST NUMBER 09N17-095, WHICH RECEIVED FDA APPROVAL. MDR 3005248192-2025-00500 IS BEING SUBMITTED FOR A SECOND LOT UTILIZED DURING THIS SAME EVENT.

Description of Event or Problem

CUSTOMER COMPLAINED ABOUT FALSE NEGATIVE RESULT ON THE CHLAMYDIA TRACHOMATIS (CT) TARGET, WHEN RUNNING THE ALINITY M STI ASSAY. SAMPLE ID (SID) (B)(6): ON (B)(6) 2025, URINE SAMPLE WAS RESUSPENDED AS PER PACK INSERT INSTRUCTIONS IN THE ALINITY M MULTICOLLECT KIT FOR URINE AND GENERATED A CT NEGATIVE, NG POSITIVE RESULT WHEN RUN ON ALINITY M STI ASSAY. AS THE POSITIVE NG RESULT REQUIRED CONFIRMATION, THE URINE SAMPLE WAS RESUSPENDED IN THE XPERT URINE MEDIA FOR CONFIRMATION ON THE GENEXPERT WHICH RETURNED A RESULT OF POSITIVE FOR CT AND NG. THE CYCLE THRESHOLD VALUE OF THE CT POSITIVE SAMPLE ON GENEXPERT WAS 31. TO RULE OUT A PRE-ANALYTICAL ERROR, A FRESH RESUSPENSION WAS PREPARED IN THE ALINITY AND RETESTED ON THE ALINITY YIELDING THE SAME RESULT OF NEGATIVE FOR CT AND POS FOR NG. THE URINE SAMPLE WAS THEN RESUSPENDED IN COBAS PCR MEDIA AND TESTED ON THE COBAS 6800, WHICH SUPPORTED THE GENEXPERT RESULT OF CT AND NG POSITIVE. AS PART OF TROUBLESHOOTING, A RANGE OF SAMPLES WERE TESTED ON THE ALINITY M INSTRUMENT INCLUDING: - THE NEAT URINE (SID (B)(6), TESTED ON (B)(6)) = CT NEG, NG POS. - 1:10 DILUTION OF THE ALINITY MEDIA SAMPLE (SID (B)(6), TESTED ON (B)(6)) = CT NEG, NG POS. - THE XPERT URINE MEDIA SAMPLE (SID (B)(6), TESTED ON (B)(6)) = CT POS, NG POS. - COBAS PCR MEDIA SAMPLE (SID (B)(6), TESTED (B)(6)) = CT POS, NG POS. CUSTOMER STATES THE RESULT WAS RELEASED AS POSITIVE FOR CT AND POSITIVE FOR NG. THERE IS NO REPORTED NEGATIVE IMPACT TO PATIENT MANAGEMENT. DATA ANALYSIS INDICATES THAT ALTHOUGH THERE IS AMPLIFICATION OF THE CT TARGET, THE MAX RATIO (MR) THRESHOLD WAS NOT MET. CUSTOMER HANDLED THE SPECIMENS ACCORDING TO GOOD LABORATORY PRACTICE AND DOES NOT BELIEVE ANY CONTAMINATION OF THE GENEXPERT MEDIA OR COBAS MEDIA COULD BE POSSIBLE. BOTH THE GENEXPERT AND COBAS MEDIA WERE PREPARED, AND THE NEAT URINE WAS RUN AFTERWARDS ON THE ALINITY M AND THE NEAT URINE WAS STILL NEGATIVE FOR CT.

Additional Manufacturer Narrative

INVESTIGATION INTO THIS COMPLAINT INCLUDED A FILE SAMPLE EVALUATION, CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: RETAIN / FILE SAMPLE EVALUATION: THE FILE SAMPLE EVALUATION FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT NUMBERS 415152 AND 417160 WAS PERFORMED. THE FILE SAMPLE EVALUATION MET ALL VALIDITY AND ACCEPTANCE CRITERIA. ALL REPLICATES INCLUDED IN THE CALCULATIONS WERE INTERPRETED CORRECTLY BY THE ASSAY SOFTWARE. THERE WERE NO ERROR CODES OR FLAGS AMONG THE REPLICATES INCLUDED IN THE CALCULATIONS. THE RESULTS FOR THE PARAMETERS BEING EVALUATED WERE WITHIN THE VALIDITY AND ACCEPTANCE CRITERIA. MOREOVER, THERE WERE NO INSTANCES OF DISCREPANT FALSE NEGATIVE RESULTS; THEREFORE, THE FILE SAMPLE EVALUATION FOR LOT NUMBERS 415152 AND 417160 MET THE ACCEPTANCE CRITERIA AND VALIDITY CRITERIA THAT WERE ESTABLISHED. AS A RESULT, THE PRODUCT FILE SAMPLE EVALUATION FOR THE ALINITY M STI AMP KIT (LIST 09N17-091) LOT NUMBERS 415152 AND 417160 RECEIVED A DISPOSITION OF PASS. CUSTOMER DATA REVIEW: ALL RELEVANT CUSTOMER DATA ATTACHED TO THE TICKET WAS REVIEWED. THE ASSAYS MET SPECIFICATION REQUIREMENTS AS NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE QUALITY CONTROL (QC) RUNS, INDICATING THE REAGENTS AND THE SYSTEM WERE PERFORMING PER SPECIFICATION. SID (B)(6) (REPLICATE IDS: (B)(6)) AND SID (B)(6) (REPLICATE ID: (B)(6)) GENERATED AMPLIFICATION CURVES FOR THE CT ANALYTE BUT HAD MAX RATIO (MR) VALUES THAT WERE BELOW THE MR THRESHOLD. THE AMPLIFICATION CURVES OF THESE REPLICATES EXHIBITED CHARACTERISTICS OF WEAK POSITIVE SAMPLES. INTERNAL AND CELLULAR CONTROLS WERE WITHIN EXPECTED RANGE, CONFIRMING THERE WAS NO PCR INHIBITION OR EXTRACTION ISSUES. THE NG ANALYTE RESULTS WERE CONSISTENTLY POSITIVE ACROSS REPLICATES (REPLICATE IDS: (B)(6)). QUALITY DATA REVIEW: CAPA REVIEW: A LOT SPECIFIC CAPA SEARCH WAS PERFORMED TO IDENTIFY RELATED EXISTING INTERNAL QUALITY RECORDS TO THE REPORTED COMPLAINT DURING PRODUCTION OR INTERNAL USE. THE LOT SPECIFIC CAPA REVIEW DID NOT IDENTIFY ANY EXISTING INTERNAL RECORDS OR NONCONFORMANCES RELATED TO THE REPORTED COMPLAINT FOR THE LOTS IN QUESTION. COMPLAINT HISTORY REVIEW: A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR ELEVATED COMPLAINTS TO THE CASE BEING INVESTIGATED, WHICH REPORTED DISCREPANT FALSE NEGATIVE RESULTS FOR THE CHLAMYDIA TRACHOMATIS (CT) ANALYTE WHILE USING ALINITY M STI AMP KIT (LIST 09N17-091) LOT NUMBERS 415152 AND 417160. THE COMPLAINT HISTORY REVIEW DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS RELATED TO THE REPORTED ISSUE FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT NUMBERS 415152 AND 417160. COMPLAINT TRENDING WAS ALSO REVIEWED. A TREND VIOLATION WAS NOT IDENTIFIED AS THE UPPER CONTROL LIMIT WAS NOT EXCEEDED FOR PRODUCT 9N17 (BASE LIST PART NUMBER). NO ADVERSE TREND WAS IDENTIFIED IN THIS DATASET. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT NUMBERS 415152 AND 417160 WAS NOT IDENTIFIED.