BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2151504 · Received June 24, 2011

    Report

    Report Number
    1061932-2011-00721
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    January 24, 2008
    Report Date
    January 25, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT CHECKSUM DIGIT IS DISABLED. PRODUCT LABELING STATES: "BECKMAN COULTER STRONGLY RECOMMENDS THE USE OF BAR-CODE CHECKSUMS TO PROVIDE AUTOMATIC CHECKS FOR READ ACCURACY." PATIENT BARCODE WAS REQUESTED BUT NOT PROVIDED. SERVICE INFORMATION WAS NOT PROVIDED. ROOT CAUSE IS FAILURE TO USE CHECKSUM FEATURE OF LH750. 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 SAMPLE MISIDENTIFICATION WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. SAMPLE WITH IDENTIFICATION NUMBER (B)(6) WAS INCORRECTLY READ AS (B)(6). THE PRINTOUT DISPLAYED A "NO MATCH" ERROR MESSAGE WHICH ALERTED THE OPERATION TO THE ERROR. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT 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