BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780

    MDR report key: 1828041 · Received September 8, 2010

    Report

    Report Number
    1061932-2010-00140
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 2, 2010
    Report Date
    September 8, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED IN 4ML BD VACUTAINER TUBES, SAMPLED FRESH AND STORED AT ROOM TEMPERATURE. QC WAS RUN BEFORE THE EVENT AND RESULTS RECOVERED WITHIN ASSAY LIMITS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE FOUND THAT THE HGB CUVETTE VENT LINE WAS PLUGGED; HE REPLACED THE TUBING AND VERIFIED THE INSTRUMENT OPERATION. A PLUG IN THE HGB CUVETTE TUBING LINE MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING ERRONEOUS LOW HEMOGLOBIN (HGB) RESULTS GENERATED BY THE COULTER LH 780 ANALYZER FOR FOUR PATIENT SPECIMENS', WITHOUT INSTRUMENT GENERATED FLAGS. THE RESULTS WERE REPORTED OUT OF THE LAB AND WERE QUESTIONED. THE ORIGINAL SPECIMENS WERE RE-TESTED ON A DIFFERENT INSTRUMENT, AND HGB RESULTS OBTAINED WERE HIGHER FOR ALL PATIENTS. THE CUSTOMER CONSIDERED THE REPEATED RESULTS CORRECT AND CORRECTED REPORTS WERE SENT OUT. THERE WAS NO CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 780

    Patients

    Seq Age Sex Outcome Treatment
    1