BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 795917 · Received December 7, 2006

    Report

    Report Number
    1034569-2006-00197
    Event Type
    Malfunction
    Date Received
    December 7, 2006
    Date of Event
    November 13, 2006
    Report Date
    December 7, 2006
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER PERFORMED A WEAK D AND FWD ABO ASSAY ON THE SAMPLE USING GALILEO. THEY RECEIVED A 3+ POSITIVE REACTION ON WEAK D AND A 1+ POSITIVE ON FWD ABO. CUSTOMER SAMPLE WAS RETURNED FOR INVESTIGATION TESTING. FWD_ABORH TESTING PERFORMED ON IN-HOUSE GALILEO WITH IN-HOUSE DONOR SAMPLES OF VARIOUS RH PHENOTYPES AND CUSTOMER'S SAMPLE. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED. PATIENT'S SAMPLE WAS INTERPRETED AS GROUP O, D POSITIVE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN RH DISCREPANCY ON THE GALILEO. A PATIENT SAMPLE TESTED AS O, RH NEGATIVE ON GALILEO. CUSTOMER TESTED THE SAMPLE BY MANUAL TUBE METHOD AND THE SAMPLE TYPE AS O, RH POSITIVE. CUSTOMER RECEIVED A NEW SAMPLE FROM THE SAME PATIENT AND REPEATED THE TESTING ON GALILEO; THE SAMPLE TYPED AS O, RH NEGATIVE. CUSTOMER MANUALLY REPEATED TESTING BY THE TUBE METHOD AND THE SAMPLE TYPE AS RH POSITIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *