BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-JKA

    MDR report key: 3845770 · Received June 3, 2014

    Report

    Report Number
    1034569-2014-00086
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 2, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102117/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT SAMPLE OR CUSTOMER PRODUCT WAS RETURNED TO IMMUCOR FOR IMMUCOR INVESTIGATION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323911 ANTI-JKA BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 614010

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR