BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2171269 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00791
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    April 8, 2008
    Report Date
    April 8, 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 FEATURE WAS DISABLED ON THE COULTER LH 750 HEMATOLOGY ANALYZER. THE BARCODE SYMBOLOGY IS CODABAR. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER EVALUATED THE ANALYZER. THE FSE REMOVED THE LASER COVER, INSPECTED THE LASER AND RAN MULTIPLE PT SAMPLES WITH NO BARCODE READ ERRORS OCCURRING. THE ROOT CAUSE WAS DETERMINED TO BE THE LACK OF USE OF THE CHECKSUM FEATURE. AS PER BCI LABELING: 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 JANUARY 1, 2008 AND OCTOBER 23, 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)(6). THE SAMPLE IDENTIFICATION BARCODE NUMBER WAS READ AS (B)(6), I.E. DROPPING THE LAST DIGIT. THE SAMPLE MISIDENTIFICATION WAS IDENTIFIED WITH A "NO MATCH" ERROR WHICH PROMPTED THE OPERATOR TO RERUN THE SAMPLE. THE SAMPLE IDENTIFICATION BARCODE NUMBER WAS THEN READ CORRECTLY. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE 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