BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2250558 · Received September 16, 2011

    Report

    Report Number
    1061932-2011-01459
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(6) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) BUT WAS UNABLE TO REPRODUCE THE RECOVERY PROBLEM. A DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 THE COULTER LH 750 HEMATOLOGY ANALYZER GENERATED AN ERRONEOUSLY ELEVATED HEMOGLOBIN (HGB) REPEAT RESULT WITH NO INSTRUMENT GENERATED FLAGS FOR A KNOWN CANCER PATIENT SAMPLE. THE INITIAL PATIENT SAMPLE RESULTS, GENERATED IN INSTRUMENT AUTOMATIC MODE, YIELDED INCOMPLETE COMPUTATION FLAGS FOR HGB, MEAN CELL HEMOGLOBIN CONCENTRATION (MCHC) AND MEAN CELL HEMOGLOBIN (MCH) RESULTS AS WELL AS LOW RED BLOOD CELL (RBC), HEMATOCRIT (HCT) AND HIGH WHITE BLOOD CELL (WBC) AND PLATELET (PLT) RESULTS AND HENCE THE REPEAT RESULT WAS PERFORMED IN MANUAL MODE. THE ERRONEOUS RESULT HGB RESULT WAS REPORTED OUTSIDE THE LABORATORY HOWEVER WAS QUESTIONED BY THE PHYSICIAN AS IT DID NOT ALIGN WITH THE PATIENT'S CLINICAL PICTURE. UPON REPEAT ON ANOTHER INSTRUMENT, A LOWER HGB RESULT WAS GENERATED THAT WAS REGARDED AS VALID. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. QUALITY CONTROLS EXECUTED DURING THE TIMEFRAME OF THE EVENT GENERATED RESULTS WITHIN ESTABLISHED SPECIFICATIONS. THE SAMPLE WAS COLLECTED IN AN ANTICOAGULANT PURPLE TOPPED TUBE AND MIXED PRIOR TO ANALYSIS.

    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 62 YR