BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M EBV AMPLIFICATION REAGENT KIT

    MDR report key: 16450192 · Received February 27, 2023

    Report

    Report Number
    3005248192-2023-00118
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    January 20, 2023
    Report Date
    May 25, 2023
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QLX
    UDI-DI
    00884999049505
    PMA / PMN Number
    K212778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ELEVATED COMPLAINT INVESTIGATION WILL BE INITIATED.

    Additional Manufacturer Narrative · 0

    THE TICKET WAS REPORTED FOR DISCREPANT RESULTS (FALSE POSITIVE) BELOW LOWER LIMIT OF QUANTIFICATION (<LLOQ) ON THE ALINITY M SYSTEM (LIST 08N53-02) WHILE USING ALINITY M EBV AMPLIFICATION (AMP) KIT, US (LIST 09N43-095) LOT 381017. THE REPORTED SAMPLE IDS IN THE COMPLAINT TICKET DEMONSTRATE THE SAME ISSUE IDENTIFIED IN THE NONCONFORMANCE FOR ALINITY M EBV CTRL KITS, RESULTING IN FALSE POSITIVE SAMPLES BELOW THE LOWER LIMIT OF QUANTIFICATION (<LLOQ). THEREFORE, THE COMPLAINT INVESTIGATION WAS DISPOSITIONED AS CONFIRMED AND LINKED TO THE ASSOCIATED RISK ASSESSMENT. INTERNAL TESTING PERFORMED AS PART OF THIS ASSESSMENT DETERMINED THAT ALL THE FALSE DETECTED SAMPLES IN THE STUDY WERE BELOW LLOQ. THE RISK ASSESSMENT CONCLUDED THAT FOR INCORRECT RESULTS, A REACTIVE NEGATIVE PATIENT SAMPLE WOULD BE AN INCORRECT RESULT OF FALSE DETECTED. A FALSE DETECTED, BELOW LLOQ, RESULT WOULD LEAD TO A POTENTIAL RETEST OF THE SAMPLE, RESULTING IN PATIENT INCONVENIENCE TO OBTAIN A NEW BLOOD SAMPLE, AND NO PATIENT HARM IS EXPECTED TO OCCUR. THERE ARE NO THERAPEUTIC CONSEQUENCES FOR THE PATIENT AND WOULD MOST LIKELY LEAD TO A RETEST OF A LEFTOVER SAMPLE OR RETEST OF A FRESHLY OBTAINED SAMPLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DISCREPANT (FALSE DETECTED) ALINITY EBV RESULTS WITH LOWER LIMIT OF QUANTIFICATION (LLOQ). SAMPLE ID, ALINITY RESULT, DATE, MAYO RESULT : (B)(6). MAYO RESULTS WERE GENERATED USING AN ALTERNATIVE PLATFORM (ROCHE MOLECULAR). THERE WAS NO IMPACT TO PATIENT MANAGEMENT FOR THE SAMPLE IDS LISTED ABOVE. MAYO RESULTS WERE RELEASED TO PROVIDER. THE REPORTED EVENT WAS CONSIDERED FALSE DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787639 ALINITY M EBV AMPLIFICATION REAGENT KIT NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF EPSTEIN-BARR VIRUS (EBV) QLX ABBOTT MOLECULAR, INC. 09N43-095 381017 00884999049505

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown