BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 2971448 · Received July 20, 2007

    Report

    Report Number
    1034569-2007-00147
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    May 21, 2007
    Report Date
    June 20, 2007
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REACTIVITIES OF THE K AND FYA ANTIGENS WERE CONFIRMED ON RETENTION CAPTURE-R READY-SCREEN (I AND II), LOTS X177, X179, AND X184 AND CAPTURE-R READY-ID, LOT ID081. THE CUSTOMER WAS TESTING A SPECIMEN THAT WAS APPROX A MONTH OLD AND DID NOT RETEST THE SAMPLE BY THE TUBE METHOD TO VERIFY THE REACTIVITY OF THE ANTIBODIES UPON PROLONGED STORAGE. THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION, IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING A PT SAMPLE TESTED ON GALILEO. TESTING PERFORMED WAS DURING VALIDATION OF THE INSTRUMENT, NO PT RESULTS WERE REPORTED. CUSTOMER STATES THAT AN ANTI-K, ANTI-FYA, AND POSSIBLE ANTI-JSA REACTING 1-2+ WERE DETECTED WHEN THE SAMPLE WAS PREVIOUSLY TESTED, APPROX A MONTH AGO, BY MANUAL TUBE METHOD USING PEG AS A POTENTIATOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR CAPTURE-R READY-ID, LOT ID081| AND X184 AND