BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1559923 · Received December 15, 2009

    Report

    Report Number
    1034569-2009-00445
    Event Type
    Malfunction
    Date Received
    December 15, 2009
    Date of Event
    November 18, 2009
    Report Date
    December 15, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK 040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE CAMERA IMAGES: WELL A6- 4+ REACTION/ 89 REACTION STRENGTH- VISUALLY POS. WELL B6- 2+ REACTION/ 50 REACTION STRENGTH- VISUALLY THERE IS A CLUMP OF CELLS IN THE MIDDLE OF THE WELL WITH NOTICABLE CLEAR AND IRREGULAR BORDER (INDICATIVE OF FIBRIN). WELL C6- 3+ REACTION/ 82 REACTION STRENGTH- VISUALLY POS. WELL D6- NEG REACTION/ 15 REACTION STRENGTH- VISUALLY NEG. THE MOST LIKELY CAUSE OF THE DISCREPANCY IS A FIBRIN CLOT IN THE SEGMENT. THE GALILEO OPERATOR MANUAL INSTRUCTS THAT CLOTTED SAMPLES SHOULD NOT BE TESTED ON THE GALILEO.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A SEGMENT FROM AN A POSITIVE UNIT HAS TYPED AS AB POSITIVE WITH THE FWD ABO ASSAY ON THE GALILEO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1