BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4890424 · Received July 5, 2015

    Report

    Report Number
    1061932-2015-01085
    Event Type
    Malfunction
    Date Received
    July 5, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 06/15/2015. THE FSE FOUND THE DIFFERENTIAL MIXING MOTOR WAS DAMAGED. THE FSE REPLACED THE MIXING MOTOR, WHICH RESOLVED THE ISSUE. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(6).

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING A LEAK ON THE COULTER LH 500 HEMATOLOGY ANALYZER THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE DIFFERENTIAL MIXING MOTOR WAS DAMAGED. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434330 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1