BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2983679 · Received February 28, 2013

    Report

    Report Number
    1061932-2013-00321
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INCORRECT MANUAL MODE CALIBRATION FACTORS WAS INADVERTENTLY ENTERED BY A FIELD SERVICE ENGINEER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY HIGH WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), HEMOGLOBIN (HGB), AND MEAN CORPUSCULAR VOLUME (MCV) RESULTS FOR ONE PATIENT SAMPLE RUN IN MANUAL MODE INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT MODE TO MODE RESULTS DID NOT MATCH AND HEMATOCRIT AND HEMOGLOBIN (H&H) CHECK FAILED DEFINITIVE MESSAGE. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. ONLY ONE MICROTAINER SAMPLE WAS RUN IN MANUAL MODE BUT THE CUSTOMER STATED THAT PRINTOUTS ARE NO LONGER AVAILABLE. NO OTHER PATIENT SAMPLES WERE AFFECTED IN THIS EVENT AS SAMPLES WERE RUN IN AUTO MODE. QUALITY CONTROLS (QC) RUN IN PRIMARY (AUTO) MODE BEFORE AND AFTER THE EVENT WERE WITHIN SPECIFICATIONS. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND NOTED THAT AN FSE HAD INADVERTENTLY ENTERED INCORRECT MANUAL MODE CALIBRATION FACTORS DURING A PREVIOUS VISIT ON (B)(4) 2013. THE FSE ADJUSTED MANUAL MODE CALIBRATION FACTORS DURING A MODE TO MODE CALIBRATION USING NORMAL CONTROL. ISSUE WAS RESOLVED AND INSTRUMENT WAS VERIFIED PER ESTABLISHED PROCEDURES. THE FSE ALSO CLEANED THE BLOOD SAMPLING VALVE AND SHEAR VALVES AS PREVENTATIVE MEASURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85832 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1