BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2210117 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01105
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    March 7, 2010
    Report Date
    March 9, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT HAVE THE CHECKSUM DIGIT FEATURE ENABLED ON THE COULTER LH 750 HEMATOLOGY ANALYZER. THERE WERE NO PARTS REPLACED ON THE ANALYZER BY FIELD SERVICE. BARCODE LABELS WERE RECEIVED AND TESTED USING THE QUICK CHECK 600/800 SERIES BAR CODE VERIFIER. THE TESTING DETERMINED THAT THE SUBMITTED LABELS FAILED SPECS FOR REFLECTIVITY OF MEDIA. THE LABEL SYMBOLOGY WAS CODABAR WITH NO CHECK CHARACTER. ROOT CAUSE WAS THE LACK OF CHECKSUM DIGIT AND FAILURE TO USE THE CHECKSUM FEATURE OF THE LH750, AND BARCODE LABELS OUT OF SPEC. PRODUCT LABELING: BECKMAN COULTER STRONGLY RECOMMENDS THE USE OF BAR-CODE CHECKSUMS TO PROVIDE AUTOMATIC CHECKS FOR READ ACCURACY. USE CHECKSUMS TO PROVIDE PROTECTION AGAINST OCCASIONAL MISREAD ERRORS CAUSED BY PROBLEMS SUCH AS DAMAGED OR MISAPPLIED LABELS. IF YOU MUST USE BAR-CODES WITHOUT CHECKSUMS, BECKMAN COULTER RECOMMENDS THAT YOU VERIFY EACH BAR-CODE READING TO ASSURE CORRECT PT IDENTIFICATION. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SAMPLE BARCODE MISIDENTIFICATION OCCURRED WITH ONE PT SAMPLE WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THERE WAS A "NO MATCH" ERROR MESSAGE WITH THE SAMPLE AND THE MISIDENTIFICATION WAS IDENTIFIED BY THE OPERATOR. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LAB. 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