BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-B (MURINE MONOCLONAL) SERIES 3

    MDR report key: 1270563 · Received December 24, 2008

    Report

    Report Number
    1034569-2008-00594
    Event Type
    Malfunction
    Date Received
    December 24, 2008
    Date of Event
    November 25, 2008
    Report Date
    December 12, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102692 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RETENTION TESTING OF ANTI-B SERIES 3, LOT 203238, WAS PERFORMED ON AN IN-HOUSE GALILEO WITH IN HOUSE DONOR SAMPLES. ALL IN-HOUSE DONOR SAMPLES TESTED TYPED AS EXPECTED. THE CUSTOMER RETURNED SAMPLES FOR INVESTIGATION TESTING. THE SAMPLES EXHIBITED 3+ HEMOLYSIS; THEREFORE REVERSE GROUP TESTING WAS NOT PERFORMED. FWD_ABORH TESTING WAS PERFORMED WITH THE CUSTOMER'S SAMPLE USING RETENTION ANTI-A, LOT 101684, AND ANTI-B SERIES 3, LOTS 203238 (CITED IN COMPLAINT) AND 203239, ON AN IN-HOUSE GALILEO. THE SAMPLE WAS INTERPRETED AS A POSITIVE, AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ABO DISCREPANCY ON THE GALILEO. A PATIENT SAMPLE RESULTED AS A POSITIVE (COMPLETE ABORH); REDRAWN CONFIRMATION SAMPLE IS FWD AB POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-B (MURINE MONOCLONAL) SERIES 3 BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 203328

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR