BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3974580 · Received August 3, 2014

    Report

    Report Number
    1061932-2014-01809
    Event Type
    Malfunction
    Date Received
    August 3, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    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 ERYTHROLYSE PUMP (PM6) AND SYABILYSE PUMP WERE FAULTY; THE TWO PUMPS WERE REPLACED RESOLVING THE R FLAG AND INCOMPLETE DIFFERENTIAL RESULT ISSUES. THE FSE CONFIRMED THE TUBE FORWARD ERRORS; THE TUBE FORWARD ASSEMBLY AND SENSOR WERE CLEANED RESOLVING THE ERRORS. ADDITIONALLY, THE FSE REPLACED SEVERAL OTHER PARTS WHILE TROUBLESHOOTING AND PERFORMED A ROUTINE PREVENTATIVE MAINTENANCE PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A COULTER LH 500 HEMATOLOGY ANALYZER WAS GENERATING R FLAGS AND INCOMPLETE DIFFERENTIAL RESULTS WHEN TESTING PATIENT SAMPLES. IN ADDITION, THE INSTRUMENT WAS GENERATING TUBE FORWARD ERRORS. THERE WERE NO ERRONEOUS NUMERICAL PATIENT 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
    452607 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1