BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2172286 · Received July 22, 2011

    Report

    Report Number
    2122870-2011-02364
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) PERFORMED CUSTOMER FEEDBACK TYPE ONE PROTOCOL TESTING, AN INSTRUMENT SYSTEM CHECK, A HIGH SENSITIVITY SYSTEM CHECK AND AN ASSAY QUALITY CONTROL ASSESSMENT. ALL RESULTS MET ESTABLISHED SPECIFICATIONS. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT. ASSOCIATED MDRS FOR THIS EVENT: 2122870-2011-02364, 2122870-2011-02416.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DISCREPANT TOTAL HUMAN CHORIONIC GONADOTROPIN (TBHCG) RESULTS WERE GENERATED ON A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEMS FOR MULTIPLE PATIENT SAMPLES OVER MULTIPLE DAYS. THIS REPORT REPRESENTS THE IMPRECISE TOTAL HUMAN CHORIONIC GONADOTROPIN (TBHCG) RESULT GENERATED ON A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ON (B)(6) 2011 FOR ONE PATIENT SAMPLE. ALL TBHCG TESTS WERE RUN IN DUPLICATE. THE REPEAT TBHCG TEST RESULT, GENERATED ON THE SAME INSTRUMENT AS THE INITIAL RESULT, WAS LOWER THAT THE INITIAL TEST RESULT. THE RESULTS WERE OUTSIDE THE INSTRUMENT'S PRECISION RANGE CLAIMS FOR THE TBHCG ASSAY. THE RESULTS WERE NOT RELEASED FROM THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE INSTRUMENT'S QUALITY CONTROL RESULTS FOR THIS ASSAY WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE TIMEFRAME OF THIS EVENT. NO ADDITIONAL SYSTEM INFORMATION WAS PROVIDED BY THE CUSTOMER. THE TBHCG SAMPLE WAS COLLECTED IN A "MINT GREEN" TOPPED PLASMA LITHIUM HEPARIN TUBE. THE SAMPLE WAS "NORMAL" IN APPEARANCE WITHOUT ANY VISIBLE ABNORMALITIES. NO ADDITIONAL PATIENT 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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS TOTAL SSHCG REAGENT