BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2183644 · Received July 8, 2011

    Report

    Report Number
    1061932-2011-00814
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHECKSUM DIGIT FEATURE OF THE LH750 WAS DISABLED. ON (B)(6) 2008, THE FIELD SERVICE ENGINEER EVALUATED THE INSTRUMENT AND VERIFIED PERFORMANCE. ROOT CAUSE WAS IDENTIFIED AS FAILURE TO USE A CHECKSUM DIGIT AND THE CHECKSUM FEATURE IN THE LH750. PRODUCT LABELING STATES: "BECKMAN COULTER STRONGLY RECOMMENDS THE USE OF BAR-CODE CHECKSUMS TO PROVIDE AUTOMATIC CHECKS FOR READ ACCURACY." THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SAMPLE MISIDENTIFICATION WHILE USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE SAMPLE IDENTIFICATION BARCODE NUMBER WAS (B)(4). THE ANALYZER READ THE BARCODE NUMBER INCORRECTLY AS (B)(4). THERE WAS A "NO MATCH" ERROR MESSAGE ASSOCIATED WITH THE TEST RESULTS. THE OPERATOR REVIEWED THE SAMPLE IDENTIFICATION WHEN THE "NO MATCH" ERROR MESSAGE WAS PRESENT AND PT DEMOGRAPHICS WERE ABSENT FROM THE PRINTOUT. TEST RESULTS FOR SAMPLE (B)(4) WERE INCORRECTLY POSTED IN THE LABORATORY INFO SYSTEM (LIS) TO A PT ASSOCIATED WITH SAMPLE IDENTIFICATION (B)(4). THE SAMPLE WAS RERUN AND THE SAMPLE IDENTIFICATION BARCODE NUMBER WAS READ CORRECTLY. THIS ISSUE WAS IDENTIFIED AND CORRECTED. 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