BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2172312 · Received June 24, 2011

    Report

    Report Number
    1061932-2011-00699
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    January 7, 2008
    Report Date
    January 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S BARCODE SYMBOLOGY WAS CODE 39. THE CHECKSUM FEATURE OF THE LH750 WAS DISABLED. AS PER PRODUCT LABELING, BECKMAN COULTER STRONGLY RECOMMENDS THE USE OF BAR-CODE CHECKSUMS TO PROVIDE AUTOMATIC CHECKS FOR READ ACCURACY. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER VERIFIED INSTRUMENT PERFORMANCE. ROOT CAUSE IS THE FAILURE TO USE CHECKSUM DIGITS AND THE CHECKSUM FEATURE OF THE LH750. 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 A COULTER LH 750 HEMATOLOGY ANALYZER. A SAMPLE IDENTIFICATION NUMBER OF #=(B)(4) WAS INCORRECTLY READ AS #=(B)(4). A "NO MATCH" ERROR MESSAGE WAS GENERATED. PT DEMOGRAPHICS WERE NOT ASSIGNED. ERRONEOUS TEST RESULTS WERE NOT 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