BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-JKB MONOCLONAL

    MDR report key: 10347300 · Received July 30, 2020

    Report

    Report Number
    1034569-2020-00050
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Report Date
    April 30, 2020
    Manufacturer
    IMMUCOR, INC.
    Product Code
    QHT
    PMA / PMN Number
    125489/0
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT ONE (1) PATIENT SAMPLE TEST USING ANTI-JKB MONOCLONAL GAMMA-CLONE REAGENT ON AUTOMATED BLOOD BANK SYSTEMS PRODUCED AN UNEXPECTED NEGATIVE RESULTS FOR THE ANTI-JKB ANTIBODY. THE RESULTS REPRESENTED A FALSE NEGATIVE DUE TO PRIOR PATIENT HISTORY OR, TESTING COMPLETED BY OTHER METHODS THAT DEMONSTRATED THE PRESENCE OF THE SPECIFIC ANTIBODY. SUBSEQUENT TESTING OF THE REAGENT RETENTION LOT AND AN ANTIGEN VALIDATION TEST OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WAS DETERMINED FOR THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812590 ANTI-JKB MONOCLONAL REAGENT RED BLOOD CELLS QHT IMMUCOR, INC. 631050

    Patients

    Seq Age Sex Outcome Treatment
    1