BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1004442 · Received November 7, 2007

    Report

    Report Number
    1034569-2007-00295
    Event Type
    Malfunction
    Date Received
    November 7, 2007
    Date of Event
    October 11, 2007
    Report Date
    November 6, 2007
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT IMAGES WERE REVIEWED AND WERE CONSISTENT WITH THE CUSTOMER'S RESULTS. UPON REVIEW OF THE IMAGES, THE OTHER REACTIONS ON THE PLATE WERE AS EXPECTED. A CENTRIFUGE, PIPETTOR, OR CAMERA READER MALFUNCTION CAN BE RULED OUT BASED ON EXPECTED REACTIONS IN THE WELLS ON THE IMAGE FOR THE OTHER DONOR SAMPLES. A DONOR SAMPLE RELATED ISSUE CAN NOT BE RULED OUT SINCE THE SAMPLES COULD HAVE BEEN HEMOLYZED OR A CLOT PRESENT. THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION TESTING. IT IS NOT POSSIBLE TO RULE OUT THE SAMPLE AS A CAUSE OF THE EVENT. FWD-ABORH WAS TESTING PERFORMED ON AN IN-HOUSE GALILEO WITH ANTI-A SERIES 1, LOTS 101676 AND 101672, ANTI-B SERIES 3, LOT 203228, ANTI-D SERIES 4, LOT 504694, AND MONOCLONAL CONTROL, LOT 492027 USING KNOWN A1, A2, B, AND O DONOR SEGMENTS. ALL DONOR SEGMENTS TYPED AS EXPECTED; NO ABO OR RH DESCREPANCIES WERE OBSERVED. A REVIEW OF THE DHR FOR ANTI-A SERIES 1, LOTS 101663, 101672, 101674, 101675/676, AND 10677/678 WAS CONDUCTED. NO DEVIATIONS FROM PROCEDURES WERE FOUND DURING REVIEW OF THE DHRS. ACCORDING TO THE GALILEO OPERATOR MANUAL, FORWARD ONLY ABO-RH TESTING HAS A HIGHER RISK OF MISTYPE DUE TO THE ABSENCE OF THE REVERSE TYPE RESULTS. HAZARDOUS MISTYPES MAY OCCUR, SUCH AS AN A SAMPLE BEING INTERPRETED AS A GROUP AB, OR AN RH (D) NEGATIVE SAMPLE BEING INTERPRETED AS RH(D) POSITIVE. FOR THIS REASON, ABO-RH RESULTS SHOULD ALWAYS BE COMPARED TO THE PATIENT OR DONOR'S HISTORY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ABO MISTYPES ON GALILEO SHORTLY AFTER THE MODIFIED FWD_ABO ASSAY WAS LOADED ON THE GALILEO. KNOWN A DONORS TYPED AS O.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1