BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3951414 · Received July 22, 2014

    Report

    Report Number
    1061932-2014-01725
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND CONFIRMED THE STABILYSE PUMP NEEDED TO BE ADJUSTED. THE FSE ADJUSTED THE STABILYSE PUMP RESOLVING THE FAILURES ON THE QUALITY CONTROL SAMPLE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED DIFFERENTIAL RESULTS WERE OUTSIDE THE ACCEPTABLE RANGE (LOW) FOR THE QUALITY CONTROL (5C CELL CONTROL - LOW LEVEL) WHEN RUN USING THE MANUAL MODE ON THE COULTER LH 500 HEMATOLOGY ANALYZER. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428669 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1