BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 3210943 · Received July 8, 2013

    Report

    Report Number
    1034569-2013-00119
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 10, 2013
    Report Date
    July 8, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR JAPAN RECEIVED THE PATIENTS SAMPLE FOR INVESTIGATION. TESTING WAS PERFORMED BY TUBE METHOD USING LISS. WEAK POSITIVE RESULTS WERE OBTAINED. THE SAMPLE WAS WASHED WITH SALINE AND TESTED BY IAT. NEGATIVE RESULTS WERE OBTAINED SUGGESTING THAT AN IGM ANTIBODY WAS PRESENT. CAPTURE IS USED FOR THE DETECTION OF IGG ANTIBODIES AS STATED IN THE PACKAGE INSERT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIVITY WITH CAPTURE-R READY-SCREEN (3), LOT J044, FOR A SAMPLE POSSIBLY CONTAINING ANTI-E AND ANTI-LEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310479 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. J044

    Patients

    Seq Age Sex Outcome Treatment
    1