BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2182772 · Received July 28, 2011

    Report

    Report Number
    2122870-2011-02523
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 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 DECLINED BY THE CUSTOMER. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. ASSOCIATED MDRS FOR THIS EVENT: 2122870-2011-02522, 2122870-2011-02523, 2122870-2011-02524.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRATIC TOTAL HUMAN CHORIONIC GONADOTROPIN (TBHCG) RESULTS WERE GENERATED FROM TWO UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEMS FOR ONE PATIENT'S SAMPLES OVER TWO DAYS. THIS REPORT IS TWO OF THREE, AND REPRESENTS THE ERRATIC TOTAL HUMAN CHORIONIC GONADOTROPIN (TBHCG) RESULTS GENERATED ON A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM, SERIAL NUMBER (B)(4), ON (B)(6) 2011. TWO PATIENT SAMPLES WERE TESTED FOUR TIMES ON THE UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)) WITH VARIED RESULTS ABOVE THE NORMAL REFERENCE RANGE AND OUTSIDE THE ASSAY'S PRECISION CLAIMS. ONE RESULT WAS GENERATED USING A REFLEX TEST, AND FOUR RESULTS WERE OBTAINED FROM ALIQUOTS OF THE ORIGINAL SAMPLE ANALYZED THROUGH THE SPU (SPECIMEN PROCESSING UNIT). NONE OF THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED WITH THIS EVENT. INSTRUMENT TBHCG QUALITY CONTROL RESULTS WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS DURING THE TIMEFRAME OF THIS EVENT. THE TBHCG SAMPLES WERE COLLECTED IN 13X100MM LITHIUM HEPARIN PLASMA TUBES WITH GEL SEPARATOR.

    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 73 YR ACCESS TOTAL SSHCG REAGENT