BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA-CLONE

    MDR report key: 9981711 · Received April 21, 2020

    Report

    Report Number
    1034569-2020-00024
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    March 25, 2020
    Report Date
    April 21, 2020
    Manufacturer
    IMMUCOR, INC.
    Product Code
    QHR
    UDI-DI
    10888234001348
    PMA / PMN Number
    BL 103523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PRODUCT NOTIFICATION ISSUED 04/16/2020 FOR GAMMA-CLONE ANTI-D (MONOCLONAL BLEND) BLOOD GROUPING REAGENT, LOTS 506300, 506301 REGARDING DECREASE IN PRODUCT POTENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447773 GAMMA-CLONE ANTI-D (MONOCLONAL BLEND) BLOOD GROUPING REAGENT QHR IMMUCOR, INC. 506301 10888234001348

    Patients

    Seq Age Sex Outcome Treatment
    1