BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 4101012 · Received September 19, 2014

    Report

    Report Number
    1061932-2014-02323
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    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 DETERMINED THE LIGHT SCATTER (LS) PREAMP WAS DEFECTIVE AND REPLACED THE PART, RESOLVING THE LATRON RECOVERY ISSUE. THE FSE COULD NOT CONFIRM THE ASPIRATION C ERRORS. AS PREVENTATIVE MAINTENANCE, THE BLOOD SAMPLING VALVE KNOB WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LOW LATRON RECOVERY AND ASPICATION C ERRORS ON A COULTER LH 750 HEMATOLOGY ANALYZER. THERE WERE NO ERRONEOUS 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
    585094 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1