BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1992528 · Received February 15, 2011

    Report

    Report Number
    2122870-2011-00371
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER: QC RUN PRIOR TO AND AFTER THE EVENT WAS WITHIN RANGE. THE SAMPLES DID NOT APPEAR TO HAVE FIBRIN OR APPEARED ATYPICAL. NO FLAGS GENERATED WITH THESE RESULTS. ON (B)(6) 2011 SYSTEM CHECK PASSED ALL SPECIFICATIONS. SERVICE WAS NOT REQUESTED. THE CUSTOMER UTILIZED THEIR STAFF BIOMED ENGINEER TO MAINTAIN AND REPAIR THE INSTRUMENT. NO HARDWARE ISSUES WERE NOTED. BIOMED REPORTED NO ISSUES WITH THE INSTRUMENT. BIOMED ENGINEER CLEANED THE REAGENT CAROUSEL. INSTRUMENT VERIFIED AS PERFORMING TO BCI PERFORMANCE SPECIFICATIONS. A CLEAR ROOT CAUSE CAN NOT BE IDENTIFIED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO RECEIVING ACCUTNI RESULTS IN THE RISK STRATIFICATION RANGE FOR MULTIPLE PATIENTS GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; HENCE PATIENTS' TREATMENT WAS NOT IMPACTED BY THE EVENT. THE SAMPLES WERE REPEATED ON AN ALTERNATE METHODOLOGY AND NEGATIVE RESULTS WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1