BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER LH 750 ANALYZER

    MDR report key: 1200386 · Received October 15, 2008

    Report

    Report Number
    1061932-2008-00053
    Event Type
    Other
    Date Received
    October 15, 2008
    Date of Event
    September 19, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT SUPPLIED. QC RECORD INFORMATION WAS REQUESTED BUT NOT PROVIDED. IT IS UNKNOWN IF PREVIOUSLY RUN PATIENT SAMPLES WERE RERUN TO CONFIRM BACK TO THE LAST ACCEPTABLE RUN. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE 09/21/08: FSE REPLACED ACTUATORS FOR HGB DRAIN CUVETTE AND WASTE DRAIN CUVETTE. FSE VERIFIED THE ACTUATORS AND VERIFIED THE INSTRUMENT OPERATIONS. ALTHOUGH THE HARDWARE ISSUES ADDRESSED BY THE FSE MAY HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FROM THE PURPOSE OF THIS REPORT. (B) (4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUS HEMOGLOBIN (HGB) RESULTS GENERATED BY THE COULTER LH 750 ANALYZER FOR SEVERAL PATIENTS. THE PATIENT SAMPLE HGB RESULTS PROVIDED BY THE CUSTOMER WERE IN THE RANGE OF 60 - 134G/DL AND THE REPEAT RESULTS WERE IN THE RANGE OF 72-96G/DL. ONE OF THE SAMPLES WAS RE-RUN ON A DIFFERENT INSTRUMENT AND GAVE A RESULT OF 89G/DL WHICH WAS CONSIDERED CORRECT. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA