BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER LH 500 ANALYZER

    MDR report key: 1912102 · Received December 1, 2010

    Report

    Report Number
    1061932-2010-00240
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    October 30, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LOQ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRE AND POST TRANSFUSION PATIENT SAMPLES WERE OBTAINED BY VENIPUNCTURE AND COLLECTED IN 5.0ML EDTA TUBES. SAMPLES WERE FRESH AND PROCESSED IN THE AUTOMATIC SAMPLING MODE. CONTROLS ARE RUN THREE TIMES DAILY AND WERE RUN APPROXIMATELY 5 HOURS PRIOR TO THE INCIDENT AND WERE WITHIN THE ASSAY LIMITS. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND SERVICED THE INSTRUMENT BY REPLACING SOME HARDWARE AND PERFORMED ADJUSTMENTS AND REPAIRS AS NEEDED. FSE RESTORED PROPER SAMPLE ASPIRATION AND VERIFIED THE SYSTEM'S OPERATION. THE ROOT CAUSE IS UNKNOWN. HOWEVER, THE SYSTEM PROVIDED INSTRUMENT GENERATED PARTIAL ASPIRATION (P) FLAGS TO ALERT THE OPERATOR TO REVIEW THE INSTRUMENT RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUS CBC RESULTS GENERATED BY THE COULTER LH 500 ANALYZER WITH INSTRUMENT GENERATED PARTIAL ASPIRATION (P) FLAGS FOR A PATIENT SAMPLE. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND THE PATIENT WAS TRANSFUSED WITH TWO UNITS OF BLOOD BASED ON THE ERRONEOUS LOW HEMOGLOBIN (HGB) RESULTS. A NEW PATIENT SAMPLE WAS OBTAINED 1 HOUR POST TRANSFUSION AND CBC ANALYSIS WAS PERFORMED. THE PHYSICIAN QUESTIONED THE INCREASED HGB RESULT AND CONCLUDED THAT THE PRE-TRANSFUSION HGB RESULT WAS INCORRECT. THE ORIGINAL RESULT WAS AMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 500 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER LOQ BECKMAN COULTER INC. LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other