BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3924151 · Received July 9, 2014

    Report

    Report Number
    1061932-2014-01596
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    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 FOUND THE DIFFERENTIAL MIXING CHAMBER MOTOR WAS NOT STOPPING AND REPLACED THE MIXING CHAMBER DRIVE ASSEMBLY. AS A PREVENTATIVE MEASURE, THE FSE REPLACED THE PINCH VALVES AND ACTUATORS. THE FSE FOUND THAT SCATTER PAK REAGENTS HAD ARRIVED CHILLED AND/OR FROZEN, WHICH CONTRIBUTED TO THE DIFFERENTIAL FLAGGING ISSUE FOR CONTROLS. NEW REAGENTS WERE SHIPPED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A COULTER LH 500 HEMATOLOGY ANALYZER WAS GENERATING DIFFERENTIAL FLAGS WHILE PROCESSING CONTROLS AND THE DIFFERENTIAL MIXING CHAMBER WAS NOT STOPPING. THE INSTRUMENT WAS POWERED ON AND OFF, BUT THE DIFFERENTIAL MIXING CHAMBER CONTINUED TO RUN AFTER REBOOT. THERE WERE NO REPORTS ERRONEOUS PATIENT RESULTS GENERATED OR OF IMPACT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400325 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1