BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 834403 · Received February 9, 2007

    Report

    Report Number
    1034569-2007-00030
    Event Type
    Malfunction
    Date Received
    February 9, 2007
    Date of Event
    January 24, 2007
    Report Date
    February 9, 2007
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    bk040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF IMAGES FROM THE INSTRUMENT SHOWED THE SAMPLE HAD BEEN RUN BEFORE AND RESULTED AS O, RH NEGATIVE BUT WAS EDITED BY THE CUSTOMER ON A SUBSEQUENT RUN TO READ O, RH POSITIVE. THE RESULT WOULD HAVE BEEN REPORTED AS "O WEAK PENDING" IF THE SAMPLE HAD NEVER BEEN TESTED ON THE INSTRUMENT. THE INSTRUMENT IS OPERATING AS EXPECTED. CUSTOMER REUSES BARCODES ON A ROTATING BASIS AND HAS BEEN ADVISED ON MULTIPLE OCCASIONS ABOUT THE RISKS OF REUSING SAMPLE BARCODES. THE EVENT IS THE RESULT OF USER ERROR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN RH DISCREPANCY WITH A PT SAMPLE ON THE GALILEO. THE CUSTOMER STATED THAT THE PT IS A KNOWN O, RH NEGATIVE PT, BUT GALILEO REPORTED THE SAMPLE AS O, RH POSITIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *