BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-JKB (MONOCLONAL) GAMMA-CLONE

    MDR report key: 5050296 · Received September 2, 2015

    Report

    Report Number
    1034569-2015-00128
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 4, 2015
    Report Date
    September 2, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    125490/0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON (B)(6) 2015, AND THE RETENTION PRODUCT PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING GAMMA-CLONE ANTI-JKB (MONOCLONAL) WITH MANUAL TESTING METHODOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582931 ANTI-JKB (MONOCLONAL) GAMMA-CLONE BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 617004

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR