BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2890453 · Received December 30, 2012

    Report

    Report Number
    1061932-2012-02950
    Event Type
    Injury
    Date Received
    December 30, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE PRIMARY ASPIRATION PUMP WAS ASPIRATING THE SAMPLE TOO FAR, PAST THE FRONT BLOOD DETECTOR ON THIS PARTICULAR SAMPLE AND DILUTED THE BLOOD WHEN IT WAS BEING DELIVERED TO THE BATHS. THE FSE REMOVED AND CLEANED THE BLOOD SAMPLING VALVE (BSV) WITH DEIONIZED WATER AND ADJUSTED THE PRIMARY ASPIRATION PUMP TO ONE INCH BEFORE THE FRONT BLOOD DETECTOR. THE FSE REANALYZED THE QUESTIONED PATIENT SAMPLE, AND THE RESULTS MATCHED THE SECONDARY MODE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE PATIENT SAMPLE WAS COLLECTED IN A 4 ML BECTON DICKINSON (BD) HEMOGARD VACUTAINER TUBE AND ANALYZED IMMEDIATELY AFTER COLLECTION. CONTROLS WERE PERFORMED PRIOR TO AND AFTER THE EVENT; ALL RESULTS WERE WITHIN THE ACCEPTABLE RANGE. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QUALITY CONTROL SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY LOW ANALYTE RESULTS, FOR ONE PATIENT, INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. ON (B)(6) 2012, THE PATIENT WAS ADMITTED TO HOSPICE BED BASED ON THE RESULTS. THE PATIENT SAMPLE WAS REANALYZED IN THE MANUAL MODE, AND THE RESULTS WERE ACCEPTABLE. THE CUSTOMER INDICATED THE LABORATORY TECHNICIAN RELEASED THE RESULTS IN SPITE THE INSTRUMENT GAVE PARTIAL ASPIRATION EACH TIME THE SAMPLE WAS ANALYZED. THE CUSTOMER STATED THE LABORATORY TECHNICIAN INTERPRETED THE RESULTS TO BE ACCEPTABLE. A RECOLLECTION SAMPLE WAS OBTAINED FROM THE PATIENT THE FOLLOWING DAY AND PARTIAL ASPIRATION WAS ALSO OBTAINED. THE CUSTOMER SENT THE PATIENT SAMPLE TO THE MAIN LABORATORY FOR FURTHER ANALYSIS. THE MAIN LABORATORY OBTAINED RESULTS THAT CORRELATED WITH THE CLINIC'S ORIGINAL INSTRUMENT. THIS PATIENT IS CURRENTLY DOING WELL AND REMAINS IN HOSPICE CARE DUE TO OTHER REASONS UNRELATED TO THE REPORTED ISSUE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization