BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 ANALYZER

    MDR report key: 2041877 · Received April 6, 2011

    Report

    Report Number
    1061932-2011-00223
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED VIA VACUTAINER, STORED ON ROCKER BED, AND WAS LESS THAN 2 HOURS OLD BEFORE TESTING. QC WAS PERFORMED BEFORE THE EVENT AND RESULTS WERE WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REPLACED LEAKY RBC DILUENT DISPENSER AND VERIFIED THE INSTRUMENT'S PERFORMANCE. HARDWARE ISSUE ADDRESSED BY THE FSE MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND STATED THAT THE COULTER LH 750 ANALYZER INTERMITTENTLY GENERATED ERRONEOUS COMPLETE BLOOD COUNT (CBC) RESULTS; HIGH RED BLOOD COUNT (RBC), HEMATOCRIT (HCT), AND PLATELET (PLT) AND LOW MEAN CELL HEMOGLOBIN CALCULATION (MCH) AND MEAN CELL HEMOGLOBIN CONCENTRATION CALCULATION (MCHC). THE SPECIMEN WAS RE-TESTED ON A DIFFERENT INSTRUMENT AND RECOVERED THE EXPECTED RESULTS. ONE PATIENT SAMPLE RESULTS ARE PROVIDED TO DEMONSTRATE THIS ISSUE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WAS NO DEATH OR INJURY AND NO REPORTS OF EFFECT TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1