BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-A (MURINE MONOCLONAL) SERIES 1

    MDR report key: 1597747 · Received February 10, 2010

    Report

    Report Number
    1034569-2010-00037
    Event Type
    Malfunction
    Date Received
    February 10, 2010
    Date of Event
    January 12, 2010
    Report Date
    February 10, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT IMAGES IS NOTED BELOW: [REACTIONS] SAMPLE 1. STRIP 1 WELL 1=0. STRIP 1 WELL 2=82. THE REVIEW OF THE IMAGE APPEARS AS A 4+ HEMAGGLUTINATION. STRIP 1 WELL 3=0; STRIP 1 WELL 4=60; [REACTIONS] SAMPLE 2. STRIP 1 WELL 1=0; STRIP 1 WELL 2=70. THE REVIEW OF THE IMAGE APPEARS AS A 4+ HEMAGGLUTINATION; STRIP 1 WELL 3=0; STRIP 1 WELL 4=60; BOTH SAMPLES CLEARLY INDICATES AN A POS. CANNOT RULE OUT USER ERROR BY PUTTING THE A POS SEGMENTS IN THE TUBES BARCODED FOR THE O POS SEGMENTS. FURTHER INVESTIGATION IN THE INSTRUMENT EVENT LOG INDICATED THAT THE CUSTOMER HAD A POSSIBLE CLOT OR BUBBLE. HOWEVER, THE MONOCONTROL WELL IN THE A POSITIVE REPORTED SAMPLES IS CLEAR OF ANY DEBRIS AND FIBRIN. (B)(4) ARAUE - FLUID EXIT ERROR. POSSIBLE BUBBLE OR CLOT. (BOARD 3). (B)(4) ARAUE - CLOT DETECTED IN SAMPLE (B)(4) COULD NOT RULE OUT PROBE INTERFERENCE IN THE TEST RESULTS. CUSTOMER WAS ADVISED TO RUN A PROBE ACCURACY TEST TO CHECK THE PROBE DELIVERY. AFTER DOING SO, CUSTOMER REPORTED THAT THE INSTRUMENT IS WORKING AS EXPECTED. GROUP ASSAY PERFORMED WITH IN-HOUSE DONOR SAMPLES OF KNOWN ABO/RH TYPES USING RETENTION ANTI-A, LOT 101722, ANTI-B SERIES 3, LOT 203281, ANTI-D SERIES 4, LOT 504731, ANTI-D SERIES 5, LOT 505570, A1 REFERENCELLS, LOT 111732, AND B REFERENCELLS, LOT 113732, ON IN-HOUSE ECHO. NO MISTYPES WERE OBSERVED. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ABO MISTYPE WHEN TESTING 2 DONOR SAMPLES WITH ANTI-A (MURINE MONOCLONAL) SERIES 1 ON THE ECHO. THE UNITS WERE RECEIVED FROM DONOR CENTERS TYPED AS O POSITIVE, BUT TYPED AS A POSITIVE ON THE ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-A (MURINE MONOCLONAL) SERIES 1 BLOOD GROUPING REAGENT KSZ IMMUCOR 101722

    Patients

    Seq Age Sex Outcome Treatment
    1