BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERCEL POWER PROCESSOR

    MDR report key: 1884347 · Received October 27, 2010

    Report

    Report Number
    2050012-2010-01077
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJI
    PMA / PMN Number
    CL1 EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IS USING SST II PLASTIC TUBES. THE SAMPLES WERE SPUN AT 1960G FOR 10 MINUTES. NO INFORMATION REGARDING PATIENTS AND THE SYSTEM WAS PROVIDED. SERVICE INFORMATION WAS REQUESTED, BUT WAS NOT SUPPLIED. THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO INCREASED NUMBER OF FALSE POSITIVE HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) RESULTS OBTAINED FROM UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER AFTER HAVING THE ANALYZER CONNECTED TO POWERCEL POWER PROCESSOR. NO PATIENT TREATMENT WAS AFFECTED BECAUSE ALL POSITIVE RESULTS WERE RUN ON CONFIRMATORY TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERCEL POWER PROCESSOR SAMPLE PROCESSING SYSTEM JJI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1