BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M STI AMPLIFICATION REAGENT KIT

    MDR report key: 19269604 · Received May 8, 2024

    Report

    Report Number
    3005248192-2024-00091
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 15, 2024
    Report Date
    September 11, 2024
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QEP
    UDI-DI
    00884999049277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED D2A DEVICE COMMON NAME FROM MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD, KIT, NUCLEIC ACID, TO NUCLEIC ACID DETECTION SYSTEM FOR NON-VIRAL MICROORGANISM(S) CAUSING SEXUALLY TRANSMITTED INFECTIONS. UPDATED D2B PRODUCT CODE FROM LSL TO QEP.

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: RETAIN SAMPLE EVALUATION THE FILE SAMPLE TESTING DID NOT IDENTIFY A PRODUCT DEFICIENCY FOR THE ALINITY M STI AMP KIT (LIST 09N17-091) LOT 397845. NO ERROR CODES OR FLAGS WERE OBSERVED FOR ALL THE SAMPLES. THE RUN PASSED THE VALIDITY AND ACCEPTANCE CRITERIA ESTABLISHED. CUSTOMER DATA REVIEW: CUSTOMER RESULT LOG FILES WERE REVIEWED. THE RUN WHICH INVOLVED THE DISCREPANT RESULT WAS VALID AND MET ASSAY SPECIFICATION REQUIREMENTS. THE VALIDITY OF THE RUN MET ASSAY SPECIFICATION REQUIREMENTS. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FROM THIS ANALYSIS. QUALITY DATA REVIEW DEVICE HISTORY RECORD / BATCH RECORD REVIEW: THE DEVICE HISTORY RECORDS (DHR) REVIEW FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 397845 (INCLUDING THE COMPONENTS) WAS PERFORMED. THE MANUFACTURING PACKETS WERE REVIEWED TO IDENTIFY ANY ISSUES RELATED TO THE REPORTED COMPLAINT DURING PRODUCTION OF THE LOT COMPONENTS. NO ISSUES WERE IDENTIFIED. NO ISSUES WERE FOUND DURING QUALITY CONTROL (QC) TESTING. CAPA / NON-CONFORMANCE REVIEW: THE CAPA REVIEW FOR ALINITY M STI AMP KIT (LIST 09N17-091) LOT 397845 (INCLUDING THE COMPONENTS) WAS PERFORMED TO IDENTIFY ANY RECORDS THAT WERE POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE SEARCH DID NOT IDENTIFY ANY RECORDS RELATED TO THE REPORTED ISSUE FOR THESE LOTS. COMPLAINT HISTORY REVIEW A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE TICKET BEING INVESTIGATED, WHICH REPORTED A DISCREPANT RESULT WHILE USING ALINITY M STI AMP KIT (LIST 09N17-091) LOT 397845. NO ADVERSE TREND WAS IDENTIFIED. 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 397845 WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NOT DETECTED RESULT FOR THE CT TARGET ON THE ALINITY M STI ASSAY. SID (SAMPLE ID) (B)(6) WAS TESTED ON (B)(6) 2024 WITH CT TARGET NOT DETECTED. THE SAMPLE WAS RETESTED THE SAME DAY AS THE NG TARGET FAILED DUE TO A FLUORESCENCE FAILURE. DURING THE REPEAT RUN, THE CT TARGET WAS DETECTED WITH A CT VALUE OF 37.43. THE FALSE NOT DETECTED RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753553 ALINITY M STI AMPLIFICATION REAGENT KIT NUCLEIC ACID DETECTION SYSTEM FOR NON-VIRAL MICROORGANISM(S) CAUSING SEXUALLY TR QEP ABBOTT MOLECULAR, INC. 397845 00884999049277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown