BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1040725 · Received May 14, 2008

    Report

    Report Number
    1034569-2008-00134
    Event Type
    Malfunction
    Date Received
    May 14, 2008
    Date of Event
    April 14, 2008
    Report Date
    May 5, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGES WERE RETRIEVED AND ANALYZED. THE WEAKD MONOLAYER INTEGRITY READ APPEARED NORMAL WITH RED CELLS EVENLY DISPERSED WITH NO PINHOLES NOR ANY OTHER ABNORMAL ARTIFACTS. THE WEAK D FINAL INTERPRETATION IMAGE APPEARED POSITIVE WHICH AGREED WITH THE 2+ REACTION GRADE GIVEN (REACTION STRENGTH 50.) THE ROI'S FOR THIS WEAK D FINAL INTERPRETATION APPEARED NORMAL AS WELL. THE CUSTOMER DID NOT RETURN SAMPLE FOR INVESTIGATION TESTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A RH DISCREPANCY ON A DONOR SAMPLE. AN UNEXPECTED POSITIVE REACTION WAS OBSEREVD IN A WEAK D ASSAY. RESULTS WERE GENERATED ON GALILEO, FOR WEAK D ASSAY.THERE WERE NO ADVERSE CONSEQUENCES SUFFERED BY THIS DONOR OR ANY PATIENT BECAUSE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC. 10221

    Patients

    Seq Age Sex Outcome Treatment
    1