BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-JKA

    MDR report key: 4209191 · Received October 29, 2014

    Report

    Report Number
    1034569-2014-00193
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 28, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102117/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON 03OCT2014 AND 06OCT2014. THE RETENTION PRODUCT PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN USING POLYCLONAL ANTI-JKA, WITH TUBE TESTING METHODOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693132 ANTI-JKA BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 614010

    Patients

    Seq Age Sex Outcome Treatment
    1