BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 863472 · Received June 8, 2007

    Report

    Report Number
    1034569-2007-00139
    Event Type
    Malfunction
    Date Received
    June 8, 2007
    Date of Event
    May 10, 2007
    Report Date
    June 8, 2007
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED TESTING BY MANUAL TUBE METHOD USING THE SAME ANTI-D REAGENT USING ON THE GALILEO AND THE SAMPLE TESTED AS O, RH NEGATIVE, USING A 15 MINUTE INCUBATION. THE CUSTOMER THEN REPEATED TESTING WITH THE TUBE METHOD USING A 30 MINUTE INCUBATION, THE SAMPLE TYPED AS O, RH POSITIVE. THE PACKAGE INSERT STATES THAT INCUBATION TIME CAN BE 15-60 MINUTES. THE CUSTOMER DID NOT RETURN SAMPLE FOR INVESTIGATION TESTING. THE NATURE OF THE SAMPLE CANNOT RULE OUTED AS CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A RH DISCREPANCY ON GALILEO. A KNOWN O, RH NEGATIVE DONOR TESTED POSITIVE FOR THE WEAK_D ASSAY. THE SAMPLE WAS RETESTED ON THE GALILEO AND THE RESULTS WERE REPORTED AS O, RH POSITIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR