BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2172126 · Received June 15, 2011

    Report

    Report Number
    1061932-2011-00585
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    October 29, 2008
    Report Date
    October 29, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CLEANED THE BARCODE READER, AND THE SAMPLE ID WAS READ CORRECTLY AFTER THE CLEANING. THE CHECKSUM DIGIT FEATURE OF THE LH750 WAS DISABLED. ON (B)(4) 2008 THE FIELD SERVICE ENGINEER PERFORMED A BARCODE READER TEST FOR 30 SAMPLES, 100% READ WAS ACHIEVED FOR ALL SCANS. THE SAMPLE BARCODE LABELS USED BY THE CUSTOMER WERE EVALUATED. THE LABEL SYMBOLOGY IS CODE 39 WITH NO CHECK CHARACTER. THE LABELS FAILED REFLECTIVITY OF MEDIA, READING FROM 71% TO 75%. THE MINIMUM SHOULD BE 80%. THE ROOT CAUSE OF THE EVENT IS ATTRIBUTED TO POOR QUALITY SAMPLE BARCODE LABELS AND LACK OF CHECKSUM DIGIT. BECKMAN COULTER RECOMMENDS USE OF CHECKSUM DIGIT FEATURE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 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 ON (B)(4) 2008. SAMPLE ID (B)(6) WAS INCORRECTLY READ AS (B)(6). THERE WAS AN INSTRUMENT GENERATED "NO MATCH" ERROR CODE. NO ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. 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 UNK