BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2223185 · Received August 12, 2011

    Report

    Report Number
    1061932-2011-01147
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 22, 2009
    Report Date
    July 22, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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)(6) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS REPORT IS FOR DAY 1 OF 3. SEE MDR # 1061932-2011-01146 FOR DAY 2 OF 3 AND MDR # 1061932-2011-01148 FOR DAY 3 OF 3. ON (B)(6) 2009, A FIELD SERVICE ENGINEER (FSE) VISITED THE SITE TO EVALUATE THE INSTRUMENT. THE FSE FOUND THE FLAG ON THE STRIPPER PLATE BROKEN. HE REPLACED THE STRIPPER PLATE AND THE TUBE DETECTOR THEN VERIFIED THE INSTRUMENT'S PERFORMANCE. SUBSEQUENTLY 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 SPECS FOR REFLECTIVITY OF MEDIA. NOTE THAT THE SAMPLE BAR CODE LABELS ARE NOT A BECKMANN 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. THE ROOT CAUSE OF THIS EVENT IS UNK; HOWEVER, THE BROKEN STRIPER PLATE COULD HAVE CONTRIBUTED TO THE MISREAD, WHICH WOULD HAVE LIKELY DISPLAYED DASHES IF THE CHECKSUM WERE ENABLED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LH750 HEMATOLOGY ANALYZER MISREAD ONE SAMPLE BARCODE IDENTIFICATION (ID) LABEL. SAMPLE ID (B)(4) WAS MIS-READ AS (B)(4). THE INSTRUMENT GENERATED A 'NO MATCH' ERROR MESSAGE ALONG WITH THE TEST RESULTS. THE CUSTOMER NOTICED THE DISCREPANCY AND RERAN THE PT SAMPLE. ON RERUN THE SAMPLE ID NUMBER WAS CORRECTLY REPORTED BY THE ANALYZER. THERE WERE NO ERRONEOUS OR MIS-IDENTIFIED TEST RESULTS REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO REPORTED CHANGES TO PT TREATMENT ASSOCIATED WITH 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 64 YR