BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ANTI-LEB MURINE MONOCLONAL

    MDR report key: 9647926 · Received January 30, 2020

    Report

    Report Number
    1034569-2020-00006
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Report Date
    January 30, 2020
    Manufacturer
    IMMUCOR, INC.
    Product Code
    QHT
    UDI-DI
    10888234001898
    PMA / PMN Number
    102707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT ONE (1) PATIENT SAMPLE TESTS USING THE ANTI-LEB REAGENT ON AN AUTOMATED BLOOD BANK SYSTEM PRODUCED AN UNEXPECTED NEGATIVE RESULT. THE RESULT REPRESENTED A FALSE NEGATIVE DUE TO PRIOR PATIENT HISTORIES OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODIES. THE MALFUNCTION DID NOT SHOW A POSITIVE RESULT AS EXPECTED FOR THE ANTI-LEB ANTIBODY ON ONE (1) OCCASION. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113777 ANTI-LEB MURINE MONOCLONAL REAGENT RED BLOOD CELLS QHT IMMUCOR, INC. 992018 10888234001898

    Patients

    Seq Age Sex Outcome Treatment
    1