BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2172323 · Received June 24, 2011

    Report

    Report Number
    1061932-2011-00660
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    December 15, 2008
    Report Date
    December 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHECKSUM FEATURE OF THE ANALYZER WAS DISABLED. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER (FSE) VERIFIED THE BARCODE READER ALIGNMENT AND PERFORMED A BARCODE READ TEST. THE CUSTOMER IS AWARE OF THE RECOMMENDATION OF BECKMAN COULTER, INC TO USE BARCODE CHECKSUM DIGITS TO PROVIDE AUTOMATIC CHECKS FOR READ ACCURACY. ROOT CAUSE WAS FAILURE TO USE CHECKSUM DIGIT AND THE CHECKSUM FEATURE IN THE ANALYZER. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SAMPLE MISIDENTIFICATION WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CORRECT SAMPLE ID NUMBER WAS (B)(6). THE SAMPLE ID NUMBER WAS INCORRECTLY READ AS (B)(6). A "NO MATCH" ERROR MESSAGE WAS GENERATED. THE SAMPLE ID WAS REREAD CORRECTLY. ERRONEOUS TEST RESULTS WERE NOT RELEASED OUTSIDE THE LABORATORY. THE CUSTOMER HAS A LABORATORY PROTOCOL THAT EACH SAMPLE ID IS MANUALLY VERIFIED BEFORE RESULTS ARE RELEASED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR