BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M STI AMPLIFICATION REAGENT KIT

    MDR report key: 19036716 · Received April 3, 2024

    Report

    Report Number
    3005248192-2024-00074
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 3, 2024
    Report Date
    September 13, 2024
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QEP
    UDI-DI
    00884999049277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED D2 FROM LSL TO QEP.

    Additional Manufacturer Narrative · 0

    DATE RECEIVED BY MANUFACTURER UPDATED TO 03/20/2024 FOR 3005248192-2024-00074.

    Additional Manufacturer Narrative · 0

    CORRECTED D4 AS THE EVENT OCCURRED OVER MULTIPLE LOT NUMBERS, THE FOLLOWING MDRS HAVE BEEN SUBMITTED WITH THE FOLLOWING REAGENT LOT NUMBERS: (LOT 393413). 3005248192-2024-00110 (LOT 394667). 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: THERE WERE ONE (1) MSG ATTACHMENT INCLUDED IN THE TICKET COMMUNICATION DESCRIBING THE SAMPLE TYPES (VAGINAL & ANAL SWABS) SID: (B)(6) VAGINAL POSITIVE, (B)(6) ANAL NEGATIVE & (B)(6) VAGINAL NEGATIVE FOR THE 3 SIDS, ADDITIONALLY RESULTS LOG WERE ATTACHED. THE VALIDITY OF THE RUNS CONTAINING THE DISCREPANT RESULTS WERE VERIFIED. THE ASSAY MET SPECIFICATION REQUIREMENTS AND NO PERFORMANCE RELATED ERROR CODES OR FLAGS WERE DISPLAYED FOR THE RUN CONTROLS. THERE IS NO INDICATION THAT THE ALINITY M STI AMP KIT (LIST 09N17-091) LOTS 393413 & 394667 ARE PERFORMING OUTSIDE OF DESIGN PERFORMANCE SPECIFICATIONS. RETAIN/FILE SAMPLE REVIEW: THE FILE SAMPLE EVALUATION FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 393413 WAS PERFORMED. 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 394667 WAS PERFORMED. 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 394667 DOES NOT REPRODUCE THE CUSTOMER'S 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 393413 (INCLUDING ITS COMPONENTS) DID NOT IDENTIFY ANY ISSUES THAT COULD RESULT IN THE REPORTED COMPLAINT. NO RECORDS RELATED TO THE REPORTED COMPLAINT WERE FOUND THAT WOULD INDICATE ANY ISSUES THAT 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) LOT 393413 (INCLUDING THE COMPONENTS) MET ALL VALIDITY AND ACCEPTANCE CRITERIA. NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE REPORTED DURING QC TESTING. REVIEW OF THE MANUFACTURING PACKET FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 394667 (INCLUDING ITS COMPONENTS) DID NOT IDENTIFY ANY ISSUES THAT COULD RESULT IN THE REPORTED COMPLAINT. NO RECORDS RELATED TO THE REPORTED COMPLAINT WERE FOUND THAT WOULD INDICATE ANY ISSUES THAT 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) LOT 394667 (INCLUDING THE COMPONENTS) MET ALL VALIDITY AND ACCEPTANCE CRITERIA. NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE REPORTED DURING QC TESTING. CAPA / NON-CONFORMANCE REVIEW: A LOT SPECIFIC AND PART SPECIFIC CAPA SEARCH WAS PERFORMED TO IDENTIFY ANY EXISTING INTERNAL QUALITY RECORDS THAT COULD RESULT IN THE REPORTED COMPLAINT DURING PRODUCTION OR INTERNAL USE. THE LOT SPECIFIC CAPA REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES OR RECORDS RELATED TO THE REPORTED COMPLAINT FOR THE REPORTED KIT LOTS 393413 AND 394667. THE PART SPECIFIC CAPA REVIEW DID NOT IDENTIFY ANY EXISTING INTERNAL RECORDS OR NONCONFORMANCES RELATED TO THE REPORTED COMPLAINT FOR PART 09N17. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW FOR PART AND KEYWORD SPECIFIC SEARCH WAS PERFORMED FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOTS 393413 AND 394667. COMPLAINT TRENDING WAS COMPLETED. A TREND VIOLATION WAS NOT IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOTS 393413 AND 394667 WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 0

    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 · 0

    THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS ON THE ALINITY M STI AMP KIT. SAMPLE ID (SID) (B)(6) WAS RUN ON 18-MAR-2024 TWICE. FIRST RESULT WAS REPORTED AS NEGATIVE FOR CHLAMYDIA TRACHOMATIS (CT) WITH A "NICE" AMPLIFICATION CURVE. THE CUSTOMER REPEATED THE TEST. THE RETEST WAS PERFORMED AGAIN ON 18-MAR-2024 AND WAS REPORTED AS POSITIVE FOR CT. SIDS (B)(6) WERE RUN ON 03-MAR-2024. THE TECHNICAL APPLICATION SPECIALIST (TAS) REVIEWED THE FILES FROM ABBOTT LINK, AND THE FILES SHOW THAT THE SAMPLE HAS BEEN REPORTED AS NEGATIVE BECAUSE THE MR VALUE WAS BELOW THRESHOLD VALUE FOR CHLAMYDIA TRACHOMATIS (0.075). THE TAS EXPLAINED THE FINDING TO THE CUSTOMER THAT THE RESULT WAS GENERATED WITHIN THE GUIDELINES OF THE ASSAY DESIGN. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING WHAT RESULTS WERE REPORTED OUTSIDE THE LAB OR IF SIDS (B)(6) WERE REPEATED. THE CUSTOMER UNDERSTOOD THE EXPLANATION PROVIDED BY SUPPORT REGARDING SAMPLE VALIDATION CRITERIA. THERE WAS NO IMPACT TO PATIENT MANAGEMENT. AS THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING SIDS (B)(6), THIS PRE FORM WILL BE RUN AGAINST 3 FALSE NEGATIVE RESULTS ON THE ALINITY M STI AMP KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690612 ALINITY M STI AMPLIFICATION REAGENT KIT NUCLEIC ACID DETECTION SYSTEM FOR NON-VIRAL MICROORGANISM(S) CAUSING SEXUALLY TR QEP ABBOTT MOLECULAR, INC. 393413 00884999049277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown