BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-B (MURINE MONOCLONAL) SERIES 3

    MDR report key: 1281303 · Received January 9, 2009

    Report

    Report Number
    1034569-2009-00008
    Event Type
    Malfunction
    Date Received
    January 9, 2009
    Date of Event
    December 11, 2008
    Report Date
    January 6, 2009
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102692 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IN-HOUSE DONOR SAMPLES WERE TESTED WITH RETENTION ANTI-B SERIES 3, LOT 203239 ON AN IN-HOUSE GALILEO. NO UNEXPECTED POSITIVE REACTIVITY WAS OBSERVED. THE GALILEO OPERATOR MANUAL STATES THAT FORWARD ONLY ABO RH TESTING HAS A HIGHER RISK OF MISTYPE DUE TO THE ABSENCE OF REVERSE TEST RESULTS. ABO RH RESULTS SHOULD ALWAYS BE COMPARED TO THE PATIENT OR DONOR'S HISTORY. THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ABO DISCREPANCY ON THE GALILEO. A DONOR SAMPLE TESTED AS AB POSITIVE ON GALILEO WITH THE FWD_ABO ASSAY, BUT WAS A POSITIVE IN MANUAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-B (MURINE MONOCLONAL) SERIES 3 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 203239

    Patients

    Seq Age Sex Outcome Treatment
    1