BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3223229 · Received July 12, 2013

    Report

    Report Number
    1061932-2013-01448
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND OBSERVED DENTS IN THE DIFFERENTIAL SHEAR/SEGMENT VALVES AND PUSH PINS (ACTUATOR RODS) WHICH WERE REPLACED DURING SERVICE. THE FSE ALSO REPLACED THE NEEDLE ASSEMBLY AND FLUSHED THE ASPIRATION PATHWAY AS PART OF ROUTINE TROUBLESHOOTING. THE FSE RAN SEVERAL SAMPLES AND NO ASPIRATION ERRORS WERE OBSERVED. RESULTS: FAILURE MODE IS ATTRIBUTED TO DENTED DIFFERENTIAL SHEAR/SEGMENT VALVES AND PUSH PINS (ACTUATOR RODS). (B)(4). ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 1061932-2013-01448, 1061932-2013-01449, 1061932-2013-01450, 1061932-2013-01451.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECURRING PARTIAL ASPIRATION ERRORS WITH ASSOCIATED P-FLAGS ON PATIENT SAMPLES INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THIS REPORT REFERENCES THE EVENT WHICH OCCURRED ON (B)(6) 2013. THE CUSTOMER REPORTED OBTAINING PARTIAL ASPIRATION ERRORS (P FLAGS) AND DIFFERENTIAL VOTEOUTS WHILE RUNNING PATIENT SAMPLES ON (B)(6) 2013. NO NUMERIC VALUES ARE GENERATED WHEN THERE IS A PARTIAL ASPIRATION ERROR OR DIFFERENTIAL VOTEOUT 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
    322990 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1