BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780

    MDR report key: 1771150 · Received July 27, 2010

    Report

    Report Number
    1061932-2010-00088
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 15, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHECKSUM DIGIT WAS DISABLED. PER PRODUCT LABELING; "BECKMAN COULTER STRONGLY RECOMMENDS THE USE OF BAR-CODE CHECKSUMS TO PROVIDE AUTOMATIC CHECKS FOR READ ACCURACY. RISK OF SAMPLE MISIDENTIFICATION. WHEN USING THE HANDHELD SCANNER, OCCASIONAL MISREAD ERRORS CAN OCCUR AS THE RESULT OF PARTIAL LABEL SCANS AND DAMAGED OR MISAPPLIED LABELS. BECKMAN COULTER RECOMMENDS THAT YOU VERIFY EACH BAR-CODE READING TO ASSURE CORRECT PATIENT IDENTIFICATION". SERVICE INFORMATION WAS NOT PROVIDED. THE ROOT CAUSE IS THAT THE CHECKSUM DIGIT WAS DISABLED BY THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT THE COULTER® LH 780 ANALYZER INCORRECTLY READ SAMPLE ID (B)(4) AS (B)(4) WITH A "NO MATCH" MESSAGE IN MANUAL MODE WITH THE HAND HELD SCANNER. THE SPECIMEN WAS RERUN BECAUSE OF THE "NO MATCH" MESSAGE AND THE INSTRUMENT CORRECTLY READ THE SAMPLE ID. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. BASED ON AVAILABLE INFORMATION THERE WAS NO EFFECT TO PATIENT TOR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 780

    Patients

    Seq Age Sex Outcome Treatment
    1