BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 3951293 · Received July 22, 2014

    Report

    Report Number
    1061932-2014-01688
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE REPLACED THE WHITE BLOOD CELL (WBC) BATH, HGB PHOTODIODE ASSEMBLY, ASPIRATION PROBE, LV11, AND THE DUAL RED BLOOD CELL (RBC) DILUENT FILTERS THAT HAD CAUSED HGB AND RBC REPRODUCIBILITY PROBLEMS. SYSTEM PERFORMANCE WAS VERIFIED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A COULTER ACT DIFF 2 ANALYZER INTERMITTENTLY GENERATED HEMOGLOBIN (HGB) VOTEOUTS WHILE PROCESSING PATIENT SAMPLES AND DURING INSTRUMENT STARTUP. THERE WERE NO ERRONEOUS NUMERICAL RESULTS GENERATED AND THERE WAS NO IMPACT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428526 COULTER ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1