BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1891585 · Received November 5, 2010

    Report

    Report Number
    1034569-2010-00234
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 5, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SERVICES REVIEWED THE CUSTOMERS RESULTS AND GALILEO SPECIFICATIONS VIA REMOTE ACCESS. THE FINAL IMAGE APPEARED VISUALLY NEGATIVE AND NOT POSITIVE AS ORIGINALLY INDICATED BY THE CUSTOMER. NO INSTRUMENT PROBLEMS WERE DETECTED. REQUESTED THAT CUSTOMER REPEAT TESTING USING THE SAME SAMPLE. RESULTS WERE POSITIVE (2+).

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIVITY ON A DONOR SAMPLE WHILE PERFORMING THE CAPTURE-R READY SCREEN (POOLED) ASSAY ON THE GALILEO INSTRUMENT.

    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