BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2221127 · Received August 23, 2011

    Report

    Report Number
    1061932-2011-01093
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS THEORIZED THAT DILUENT WAS BEING INTRODUCED INTO THE SAMPLE TUBE WITH ASPIRATION, THEREBY MAKING THE SAMPLE PROGRESSIVELY MORE DILUTE AND THEREBY CAUSING REPEAT VALUES TO TREND LOW WHICH YIELDED AN INCREASED % COEFFICIENT OF VARIATION ON THE REPRODUCIBILITY ASSESSMENT AND ERRONEOUS PATIENT RESULTS. SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND THE SOLENOID THAT ACTIVATES VL (PINCH VALVE) 33 (NEEDLE VENT VACUUM) DISCONNECTED AND THE VLS SWITCH IN THE OFF POSITION. HE RECONNECTED THE SOLENOID AND RESET THE VLS SWITCH TO THE ON POSITION. HE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES AND INSTRUMENT PERFORMANCE RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. THE INSTRUMENT WAS RETURNED INTO SERVICE UPON THE COMPLETION AND VERIFICATION OF REPAIRS. THE ROOT CAUSE IS ATTRIBUTED TO SOLENOID 33 BEING DISCONNECTED; AS A RESULT, THE NEEDLE VENT LINE WAS NOT RECEIVING VACUUM FOLLOWING THE RINSE CYCLE AND DILUENT FROM THE VENT LINE WAS INTRODUCED TO THE SAMPLE TUBE DURING ASPIRATION. ADDITIONALLY, THE SENSOR WAS TURNED OFF SO THE OPERATOR WAS NOT ALERTED TO THE PROBLEM. MDRS ASSOCIATED WITH THIS EVENT: 1061932-2011-01093, 1061932-2011-01280, 1061932-2011-01281.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS REPEAT WHITE BLOOD CELLS (WBC), RED BLOOD CELLS (RBC), HEMOGLOBIN (HGB), HEMATOCRIT (HCT) AND PLATELET (PLT) RESULTS WERE GENERATED ON A COULTER LH 750 HEMATOLOGY ANALYZER FOR THREE PATIENT SAMPLES OVER THREE LABORATORY OPERATIONAL SHIFTS. THIS REPORT IS ONE OF THREE AND REPRESENTS THE ERRONEOUS WHITE BLOOD CELLS (WBC), RED BLOOD CELLS (RBC), HEMOGLOBIN (HGB), HEMATOCRIT (HCT) AND PLATELET (PLT) REPEAT RESULTS GENERATED FOR ONE PATIENT ON (B)(4) 2011. THE INITIAL RESULTS FOR THESE PATIENTS WERE REGARDED AS CORRECT. THE CUSTOMER PERFORMED A REPRODUCIBILITY ASSESSMENT AND FELT THE REPEAT RESULTS WERE TRENDING LOW AND THE % COEFFICIENT OF VARIATION WAS HIGH. OPERATION OF THE INSTRUMENT WAS CEASED PENDING BECKMAN COULTER INC. SERVICE. ERRONEOUS REPEAT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, HOWEVER, THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. A REVIEW OF CUSTOMER SUPPLIED DATA INDICATED THAT THE INSTRUMENT QUALITY CONTROL RESULTS WERE RECOVERING WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS, AND DID NOT REFLECT TRENDING, DURING THE TIMEFRAME OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1