ALINITY M STI AMPLIFICATION REAGENT KIT

Additional Manufacturer Narrative

INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, RETAIN/FILE SAMPLE REVIEW, A QUALITY DATA REVIEW, AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: CUSTOMER DATA REVIEW: TWO ATTACHMENTS WERE REVIEWED FOR THIS INVESTIGATION. BASED ON THE CUSTOMER ATTACHMENT REVIEW, THE CUSTOMER'S OBSERVATIONS WERE VERIFIED. PER THE TICKET TEXT, THE CUSTOMER TESTED SID: (B)(6) ON AN ALTERNATE PLATFORM (HOLOGIC SYSTEM) AND RECEIVED VARYING RESULTS. DIFFERENT PLATFORMS HAVE DIFFERENT SENSITIVITIES AND SPECIFICITIES FOR THE ASSAY. THEREFORE, THE RESULTS REPORTED ON THE ALINITY M SYSTEM MAY NOT ALWAYS BE IN AGREEMENT WITH OTHER TECHNOLOGIES. THE ASSAY MET SPECIFICATION REQUIREMENTS AS NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE RUN CONTROLS. THE AMPLIFICATION CURVES APPEARED NORMAL AND EXHIBITED NORMAL AMPLIFICATION. THE ASSAY IS PERFORMING AS EXPECTED WITH CORRECT INTERPRETATIONS. RESULTS FROM THE ALINITY M STI ASSAY SHOULD BE INTERPRETED IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS. RETAIN/FILE SAMPLE REVIEW: THE FILE SAMPLE EVALUATION FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 393413 WAS PERFORMED. ONE (1) TUBE OF NC (STI NEG CTRL) AND ONE (1) TUBE OF PC (STI POS CTRL) WERE LOADED ON THE ALINITY M SYSTEM FOR ORDER FOR CONTROLS, AND THE RESULTS PASSED. ALL THE REPLICATES PASSED WITH NO ERROR CODES PRESENTED AND NO INSTANCES OF FALSE NEGATIVE RESULTS. THEREFORE, THE PRODUCT FILE SAMPLE EVALUATION FOR THE ALINITY M STI AMP KIT (LIST 09N17-091) LOT 393413 DOES NOT REPRODUCE THE CUSTOMER'S OBSERVATION. THE FILE SAMPLE EVALUATION FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 384924 WAS PERFORMED. A SET OF STI NEGATIVE CONTROL (1 TUBE), STI POSITIVE CONTROL (1 TUBE) WERE LOADED ON, AND RESULTS PASSED. THE ORDERS OF TEST SAMPLES WERE ACCORDING TO THE QP. ALL REPLICATES PASSED WITH NO ERROR CODES PRESENTED AND NO INSTANCES OF FALSE NEGATIVE. THEREFORE, THE PRODUCT FILE SAMPLE EVALUATION FOR THE ALINITY M STI AMP (LIST 09N17-91) LOT 384924 DOES NOT VERIFY THE CUSTOMER OBSERVATION. QUALITY DATA REVIEW: DEVICE HISTORY RECORD / BATCH RECORD REVIEW: REVIEW OF THE MANUFACTURING PACKET FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 384924 (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. REVIEW OF THE MANUFACTURING PACKET FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 393413 (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. THE QUALITY CONTROL (QC) AMP KIT MASTERLOT TESTING FOR THE ALINITY M STI AMP KIT (LIST 09N17-091) LOTS 384924 AND 393413 (INCLUDING THE COMPONENTS) MET ALL VALIDITY AND ACCEPTANCE CRITERIA. NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE REPORTED DURING QC TESTING. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS REVIEW. CAPA / NON-CONFORMANCE REVIEW: A LOT SPECIFIC CAPA SEARCH WAS PERFORMED TO IDENTIFY ANY EXISTING INTERNAL QUALITY RECORDS WHICH COULD RESULT IN THE REPORTED COMPLAINT DURING PRODUCTION OR INTERNAL USE. KIT LOTS 384924 AND 393413 ALONG WITH THE COMPONENTS LOTS WERE SEARCHED. THE CAPA REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES RELATED TO THE REPORTED COMPLAINT FOR THE REPORTED LOTS 384924 AND 393413 (AND COMPONENTS LOTS).A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS REVIEW. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY REVIEW WAS COMPLETED TO IDENTIFY DISCREPANT RESULTS FOR FALSE NEGATIVE RESULTS WHILE USING THE ALINITY M STI AMP KIT (LIST 09N17-091) LOT 393413 AND LOT 384924. COMPLAINT TRENDING WAS COMPLETED. A TREND VIOLATION WAS NOT IDENTIFIED, AND THE UPPER CONTROL LIMIT WAS NOT EXCEEDED FOR PRODUCT 09N17. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION A PRODUCT DEFICIENCY FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOTS 384924 AND 393413 WAS NOT IDENTIFIED.

Additional Manufacturer Narrative

ADDITIONAL LOT NUMBER HAS BEEN IDENTIFIED. AS THE EVENT OCCURRED OVER MULTIPLE LOTS, THE FOLLOWING MDR HAS BEEN SUBMITTED: 3005248192-2024-00085.

Additional Manufacturer Narrative

ELEVATED COMPLAINT INVESTIGATION WILL BE INITIATED. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN FRANCE 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 TWO FALSE NEGATIVE RESULTS AND TWO QUESTIONED RESULTS ON THE ALINITY M STI ASSAY. THE CUSTOMER REQUESTED EXPLANATION REGARDING A STI SAMPLE BEING TESTED ON THE ALINITY M STI ASSAY. THE CUSTOMER REPORTED AN AMPLIFICATION CURVE FOR THE CYCLE THRESHOLD (CT) PARAMETER, BUT THE ALINITY M INSTRUMENT WAS REPORTING THE RESULT AS NEGATIVE. THE TECHNICAL APPLICATION SPECIALIST (TAS) PERFORMED LOG FILE ANALYSIS. CUSTOMER ANALYZED THE SAMPLE TWICE ON DIFFERENT DAYS, AND BOTH RESULTS WERE NEGATIVE (SAMPLE ID [SID] (B)(6) ON (B)(6) 2024 AND SID (B)(6) ON (B)(6) 2024). FOR BOTH CASES, AN AMPLIFICATION CURVE WAS OBSERVED AND STARTING AT AROUND 32 CT. THE INTERPRETED RESULT IS REPORTED AS NEGATIVE DUE TO TWO VALIDATION PARAMETERS (THE CT TARGET ITSELF AND THE MAX RATIO [MR]) WHICH ARE NOT MEETING THE EXPECTED CRITERIA AS PER THE PACKAGE INSERT. THE VALUE OF CT AND MR WERE WITHIN THE VALIDATION VALUES. TAS EXPLAINED THOSE FINDINGS TO CUSTOMER AND EXPLAINED WHY THE RESULT IS GIVING -1 WITH NO ERROR CODE GENERATED. TAS EXPLAINED THE ROOT CAUSES AND SUGGESTED TO RETEST SAMPLE WITH ANOTHER TECHNIQUE OR TO RETRY GETTING A FRESH SAMPLE. DURING FOLLOW-UP, THE CUSTOMER REPORTED THAT SID (B)(6) WAS RETESTED. PCR WAS PROCESSED ON THE HOLOGIC SYSTEM AND SAMPLE IS COMING FROM AN ESWAB. RESULT HAS BEEN REPORTED AS POSITIVE ON CT. CUSTOMER IS CONFIRMING BY THIS CONTROL TEST THAT THE SAMPLE IS A FALSE NEGATIVE. ON FEBRUARY 13, 2023, THE CUSTOMER REPORTED AN ADDITIONAL 3 CASES WITH UNINTERPRETABLE STI RESULTS REPORTED AS NEGATIVE BUT HAVING AN AMPLIFICATION CURVE. THE RESULTS WERE REPEATED ON (B)(6) 2024 WITH THE FOLLOWING RESULTS: SID (B)(6): POSITIVE. SID (B)(6): NEGATIVE WITH NO AMPLIFICATION. SID (B)(6): NEGATIVE WITH AMPLIFICATION. THE TAS CHECKED THE CURVES, AND THE CT TARGET CURVES WERE INDEED WITH AN AMPLIFIED SIGMOIDAL SHAPE CURVE FOR SIDS (B)(6). THE TAS CONFIRMED SID (B)(6) HAD NO AMPLIFICATION. NO IMPACT ON PATIENT MANAGEMENT. THE PATIENT WAS WEAKLY SYMPTOMATIC ON JANUARY 9, SO THERE WAS NO CLINICAL IMPACT DUE TO THE DELAY OF REPORTING THE RESULT. THE CLINICIAN HAS BEEN NOTIFIED OF THE RESULT. CUSTOMER DIDN'T REPORT THE RESULTS.

Additional Manufacturer Narrative

CORRECTED D2 FROM LSL TO QEP.