BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1211354 · Received October 28, 2008

    Report

    Report Number
    1034569-2008-00520
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 27, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IN-HOUSE DONOR SAMPLES AND CUSTOMER'S RETURNED SAMPLES WERE TESTED USING ANTI-D SERIES 4, LOT 504696, AND ANTI-D SERIES 5, LOT 505547, BY REFLEXABO ASSAY ON AN IN-HOUSE GALILEO. ALL IN-HOUSE DONOR SAMPLES WERE INTERPRETED AS EXPECTED. THE CUSTOMER'S SAMPLES WERE NONREACTIVE. RH RESULTS WERE INTERPRETED AS "PENDING"; 4+ HEMOLYSIS OBSERVED IN BOTH SAMPLES. MANUAL TUBE TESTING WAS PERFORMED WITH CUSTOMER'S SAMPLES 1679405 AND 1624405 USING A VARIETY OF MANUFACTURERS' ANTI-D REAGENTS, INCLUDING ANTI-D SERIES 4, LOT 504696, ANTI-D SERIES 5, LOT 505547, AND ANTI-D (MONOCLONAL BLEND), LOT DMB66-1. BOTH SAMPLES WERE NONREACTIVE WITH ALL ANTI-D REAGENTS TESTED.D TESTING WAS PERFORMED USING CUSTOMER'S SAMPLES WITH CAPTURE-R SELECT, LOT SC080, AND A VARIETY OF MANUFACTURERS' ANTI-D REAGENTS, INCLUDING ANTI-D SERIES 4, LOT 504696, ANTI-D SERIES 5, LOT 505547, AND ANTI-D (MONOCLONAL BLEND), LOT DMB66-1. THE SAMPLES WERE NONREACTIVE WITH ALL ANTI-D REAGENTS TESTED.THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.THE GALILEO OPERATOR MANUAL STATES THAT SAMPLES THAT EXHIBIT A HEMOLYSIS OF 3+ OR GREATER MUST NOT BE TESTED ON THE GALILEO, BECAUSE THEY MAY GENERATE ERRONEOUS RESULTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN RH DISCREPANCY ON GALILEO. A DONOR THAT WAS PREVIOUSLY RH NEGATIVE IS NOW REPORTING AS A RH POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1