BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4003893 · Received August 12, 2014

    Report

    Report Number
    1061932-2014-01893
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 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, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE CONFIRMED THE LEAK AND REPLACED THE BLOOD SAMPLING VALVE WITHOUT FURTHER ERRORS AND ALSO COMPLETED AN INSTRUMENT PREVENTATIVE MAINTENANCE (PM). THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. BEC REQUESTED SAMPLE PRINT OUTS SHOWING THE HEMOGLOBIN AND HEMATOCRIT (H/H) DISCREPANCY FOR EVALUATION BUT WERE NOT PROVIDED BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LESS THAN 1 ML OF CLEAR FLUID LEAKED FROM THE COULTER LH 500 HEMATOLOGY ANALYZER DURING STARTUP. IN ADDITION, THE HEMOGLOBIN AND HEMATOCRIT (H/H) NOT MATCHING SAMPLES RUN THROUGH MANUAL MODE. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479961 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1