BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-B (MURINE MONOCLONAL) SERIES 3

    MDR report key: 1409153 · Received July 6, 2009

    Report

    Report Number
    1034569-2009-00230
    Event Type
    Malfunction
    Date Received
    July 6, 2009
    Date of Event
    June 9, 2009
    Report Date
    July 1, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    102692 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH RETENTION ANTI-A, LOT 101700, ANTI-B SERIES 3, LOT 203261, ANTI-B, LOT 205016, MONOCLONAL CONTROL, LOT 492034, AND GAMMA-CLONE CONTROL, LOT 350003-2, USING A1 REFERENCELLS, LOT 111705, B REFERENCELLS, LOT 113705, AND IN-HOUSE DONOR SAMPLES OF KNOWN ABO GROUPS. THESE REAGENTS WERE USED BY THE CUSTOMER AT THE TIME OF THE EVENT. AT IS, ALL GROUP A IN-HOUSE DONOR SAMPLES AND A1 REFERENCELLS EXHIBITED STRONG REACTIVITY (4+) WITH ANTI-A REAGENT AND WERE NONREACTIVE WITH ANTI-B REAGENTS, B REFERENCELLS AND ALL GROUP B IN-HOUSE DONOR SAMPLES EXHIBITED STRONG REACTIVITY (4+) WITH ANTI-B REAGENTS AND WERE NONREACTIVE WITH ANTI-A REAGENT. ALL TESTING WITH MONOCLONAL CONTROL AND GAMMA-CLONE CONTROL WAS NEGATIVE. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH RETURNED ANTI-B SERIES 3, LOTS 203261 AND 203270, USING A1 REFERENCELLS, LOT 111704, B REFERENCELLS, LOT 113704, AND IN-HOUSE DONOR SAMPLES OF KNOWN ABO GROUPS. AT IMMEDIATE SPIN, ALL GROUP B AND AB IN-HOUSE DONOR SAMPLES EXHIBITED STRONG REACTIVITY (4+) WITH ALL ANTI-B REAGENTS AND ALL GROUP A AND O SAMPLES WERE NONREACTIVE AS EXPECTED. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH CUSTOMER'S RETURNED SAMPLE USING RETURNED ANTI-B SERIES 3, LOTS 203261 AND 203270, RETENTION ANTI-B SERIES 3, LOT 203261, AND RETENTION ANTI-B GAMMA-CLONE, LOT 205016, WITH CORRESPONDING MONOCLONAL CONTROL, LOT 492029, AND GAMMA-CLONE CONTROL, LOT 350004. SAMPLE WAS NONREACTIVE AT IMMEDIATE SPIN WITH ALL REAGENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED WEAK REACTIVITY WITH ANTI-B SERIES 3 IN A PATIENT SAMPLE (CORD AND HEEL STICK SAMPLES). CUSTOMER OBTAINED WEAK MACROSCOPIC REACTIVITY WITH ANTI-B SERIES 3 LOT 203261, AND NEGATIVE REACTIVITY USING ANTI-B GAMMACLONE LOT 205016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-B (MURINE MONOCLONAL) SERIES 3 BLOOD GROUPING REAGENT KSZ IMMUCOR 203261

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA