BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 INSTRUMENT

    MDR report key: 2072343 · Received April 28, 2011

    Report

    Report Number
    1061932-2011-00323
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIMENS WERE COLLECTED IN A BD VACUTAINER 5 ML TUBE AND ANALYZED IN PRIMARY MODE RIGHT AFTER DRAW. PREVIOUSLY-RUN PATIENT SAMPLES WERE RERUN TO CONFIRM ACCURATE BACK TO THE LAST ACCEPTABLE CONTROL RUN. CONTROLS WERE RUN BEFORE THE INCIDENT AND RECOVERED WITHIN QC RANGE. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND A PLUG IN THE PROBE AND LOOSE WIRE TO PELTIER. THE ROOT CAUSE IS A PLUG IN THE MANUAL ASPIRATION PROBE. PER LABELING, BECKMAN COULTER RECOMMENDS REVIEW, APPROPRIATE TO THE REQUIREMENTS OF THE PATIENT POPULATION, OF ALL RESULTS DISPLAYING A FLAG, CODE OR MESSAGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER LH 500 INSTRUMENT GAVE ERRATICALLY LOW MANUAL MODE COMPLETE BLOOD COUNT (CBC) AND/OR DIFFERENTIAL RESULTS FOR THREE (3) PATIENT SAMPLES WITH INSTRUMENT GENERATED CODES OR MESSAGES FOR DIFFERENTIAL, PLATELET (PLT), MEAN CELL VOLUME (MCV) AND MOST INDICES. THERE WAS NO INSTRUMENT FLAGGING FOR WHITE BLOOD COUNT (WBC), RED BLOOD COUNT (RBC), OR HEMOGLOBIN (HGB). ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER STATED THAT THE SAMPLES WERE SENT TO A LOCAL HOSPITAL FOR RERUN. THE CUSTOMER PROVIDED AUTO MODE RESULTS FOR TWO (2) OF THE THREE (3) PATIENTS. CORRECT RESULTS WERE NOT PROVIDED. NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 INSTRUMENT AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1