BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC-T DIFF 2¿ ANALYZER

    MDR report key: 2250560 · Received September 16, 2011

    Report

    Report Number
    1061932-2011-01457
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(6) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE DILUENT AND SAMPLE FMI (FLUID METERING INDEX) PUMPS, AS WELL AS THE WASTE PUMP. AFTER THE REPAIRS THE INSTRUMENT QUALITY CONTROL RESULTS SHIFTED HIGH. THE FSE ADJUSTED THE CALIBRATION FACTORS TO QUALITY CONTROL RESULTS. SUBSEQUENTLY, THE INSTRUMENT WAS CYCLED FOR 2 HOURS WITHOUT FURTHER PROBLEMS. UPON COMPLETION OF VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO SERVICE. THE ROOT CAUSE FOR THIS EVENT CAN BE ATTRIBUTED TO DILUENT, FMI, & WASTE PUMP DEFICIENCIES AND POSSIBLE INSTRUMENT ADJUSTMENT/ALIGNMENT ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 LOW, NON-REPRODUCIBLE RED BLOOD CELL RESULTS (RBC) AND (PLT) RESULTS WITHOUT INSTRUMENT FLAGS WERE GENERATED ON A COULTER AC-T DIFF 2, ANALYZER FOR TWO PATIENTS. THE SECOND PATIENT'S RESULTS ALSO POSSESSED INITIAL ERRONEOUSLY LOW HEMOGLOBIN (HGB) RESULTS. UPON REPEAT ON THE SAME INSTRUMENT, THE REPEAT RESULTS WERE CONSIDERED VALID. THE LOW, NON-REPRODUCIBLE RESULTS WERE NOT RELEASED FROM THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INSTRUMENT CONTROL RESULTS PRIOR TO THE EVENT WERE WITHIN THE CUSTOMER'S ESTABLISHED SPECIFICATIONS. SAMPLES WERE COLLECTED IN LAVENDER TOP, ANTICOAGULANT 2ML TUBES AND RUN IN CLOSED VIAL WHOLE BLOOD (CVWB) MODE. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® AC-T DIFF 2¿ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1