BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2615319 · Received June 13, 2012

    Report

    Report Number
    2122870-2012-01471
    Event Type
    Injury
    Date Received
    June 13, 2012
    Date of Event
    March 5, 2012
    Report Date
    May 22, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JNL
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2012 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) CLEANED THE ANALYTICAL MODULE AND REPLACED THE GRIPPER MIXERS AND PERI-PUMP TUBING. THE FSE ALSO REPLACED THE SAMPLE PROBE AND WASH NOZZLE DUE TO A FAILED CARRYOVER TEST. THE FSE REVIEWED THE CUSTOMER'S EVENT LOG AND ERRORS. BASED UPON THIS REVIEW THE FSE INDICATED THAT IT IS POSSIBLE THAT THE INSTRUMENT EXPERIENCED A PROBE CRASH, HOWEVER, THIS WAS NOT CONFIRMED. UPON COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2012-01471, 2122870-2012-00878.

    Description of Event or Problem · 1

    THE CUSTOMER PROVIDED ADDITIONAL INFORMATION IN REGARDS TO A PREVIOUSLY SUBMITTED MEDICAL DEVICE REPORT (2122870-2012-00878) WHICH INVOLVED THE GENERATION OF MULTIPLE ERRONEOUS PATIENT RESULTS FROM A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM. ONE OF THE ERRONEOUS PATIENT RESULTS INVOLVED IN THE EVENT WAS AN ERRONEOUSLY ELEVATED THYROGLOBULIN RESULT. THE ERRONEOUS THYROGLOBULIN RESULT WAS REPORTED OUT OF THE LABORATORY AND THE PATIENT UNDERWENT UNNECESSARY SURGERY BASED UPON THE ERRONEOUS RESULT. THE DETAILS AND IMPACT OF THIS SURGERY ON THE PATIENT ARE CURRENTLY UNKNOWN. REPEAT THYROGLOBULIN TESTING DID NOT MATCH THE ORIGINAL RESULT OBTAINED. QUALITY CONTROL RESULTS WERE RECOVERING WITH THE CUSTOMER'S ESTABLISHED SPECIFICATIONS DURING THE TIMEFRAME OF THIS EVENT. NO PATIENT SPECIFIC INFORMATION, ACTUAL PATIENT RESULTS, SYSTEM ASSAY PERFORMANCE INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JNL BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention