BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 2331301 · Received November 10, 2011

    Report

    Report Number
    1034569-2011-00178
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    October 17, 2011
    Report Date
    November 9, 2011
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULTS: CRRID PLATE ID (B)(6), LOT ID145, INDICATOR RED CELLS: LOT 221724, EXP 27OCT2011. CELLS 3 AND 6 ARE POSITIVE FOR ANTI-E ON LOT ID145 MASTERLIST. CELL 3 IS DISPLAYING WEAK REACTIVITY, CELL 6 VISUALLY APPEARS NEGATIVE. BOTH CELLS RESULTED NEGATIVE. A SERVICE CALL WAS MADE. PERFORMED GALILEO UNEXPECTED REACTION CHECK. CHECKED AND CLEANED WASHER MANIFOLD. THE SYSTEM WAS TESTED AND IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN TESTING A SAMPLE WITH A KNOWN ANTI-E WITH THE CAPTURE-R READY-ID (CRRID) ASSAY ON THE GALILEO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR