BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2171224 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00796
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    July 16, 2009
    Report Date
    July 16, 2009
    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

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(4), 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THREE SAMPLE BAR CODE LABELS WERE RECEIVED FROM THE SITE AND WERE TESTED USING THE QUICK CHECK 600/800 SERIES BAR CODE VERIFIER. THE LABEL SYMBOLOGY IS CODABAR WITH NO CHECK CHARACTER. THE SAMPLE LABELS FAILED SPECIFICATIONS FOR REFLECTIVITY OF MEDIA. NOTE THAT THE SAMPLE BAR CODE LABELS ARE NOT A BECKMAN COULTER INC PRODUCT. IT WAS NOTED THAT THE BAR CODE CHECKSUM SOFTWARE ALGORITHM FOR THE LH750 ANALYZER WAS DISABLED. PER BECKMAN COULTER LABELING, THE USE OF BAR CODE CHECKSUMS IS STRONGLY RECOMMENDED IN ORDER TO PROVIDE AUTOMATIC CHECKS FOR READ ACCURACY. THERE WAS NO SERVICE INFORMATION PROVIDED IN CONNECTION WITH THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LH750 HEMATOLOGY ANALYZER MISREAD THE SAMPLE BARCODE LABEL FOR (B)(6) AS (B)(6) WITH A NO MATCH MESSAGE ACCOMPANYING THE INSTRUMENT READOUT. THE SAMPLE BARCODE LABEL WAS RE-READ AND WAS CORRECTLY IDENTIFIED UPON REPEAT. THERE WERE NO ERRONEOUS OR MIS-IDENTIFIED RESULTS REPORTED OUTSIDE THE LABORATORY. THERE WERE NO REPORTED CHANGES TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK