BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2160279 · Received June 2, 2011

    Report

    Report Number
    1061932-2011-00539
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    September 12, 2008
    Report Date
    September 12, 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

    Narratives

    Additional Manufacturer Narrative · 1

    LABEL BARCODE SYMBOLOGY WAS CODABAR, WITH 10 CHARACTERS, WITHOUT CHECKSUM DIGIT. THE ANALYZER WAS CONFIGURED WITH THE CHECKSUM DIGIT FEATURE DISABLED. FIELD SERVICE INFORMATION WAS NOT AVAILABLE. THE INVESTIGATION INCLUDED AN ANALYSIS OF TWO BARCODE LABELS RECEIVED FROM THE CUSTOMER. USING THE QUICK CHECK (B)(4) SERIES BARCODE VERIFIER, THE BARCODE LABELS FAILED THE REQUIRED SPECIFICATION FOR REFLECTIVITY OF MEDIA, WITH 67% FOR A MINIMUM REQUIREMENT OF 80%. IT WAS ALSO CONFIRMED THAT THE BARCODE LABELS WERE CODABAR WITH NO CHECKSUM DIGIT. THE ROOT CAUSE IS THAT THE ANALYZER WAS CONFIGURED WITH THE CHECKSUM DIGIT FEATURE DISABLED AND THE POOR QUALITY OF THE BARCODE LABELS. PER LABELING, BECKMAN COULTER STRONGLY RECOMMENDS THE USE OF BARCODE CHECKSUMS TO PROVIDE AUTOMATIC CHECKS FOR READ. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, CUSTOMER REPORTED A BARCODE MISIDENTIFICATION OF A SAMPLE ID WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. A SAMPLE ID OF (B)(6) WAS INCORRECTLY READ AS (B)(6) ON (B)(6) 2008. THE ANALYZER GENERATED A "NO MATCH" ERROR MESSAGE. TEST RESULTS WERE NOT 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