BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2001934 · Received February 27, 2011

    Report

    Report Number
    2122870-2011-00487
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE COLLECTION OR SYSTEM INFORMATION WAS SUPPLIED. THE CUSTOMER HAS AN AUTOMATIC RERUN PROTOCOL FOR ALL INITIAL ACCUTNI RESULTS WHICH ARE "UNEXPECTED". SAMPLES ARE RE-CENTRIFUGED BEFORE RERUN. SERVICE WAS NOT DISPATCHED, AS CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE. NO CLEAR ROOT CAUSE HAS BEEN DETERMINED.

    Description of Event or Problem · 1

    BECKMAN COULTER INC., (BCI) CONTACTED THIS CUSTOMER VIA THE TROPONIN (ACCUTNI) MARKETING SURVEY PROGRAM (MSP) CUSTOMER CONTACT PROGRAM. THE CUSTOMER STATED THAT THEIR LABORATORY HAD OBTAINED NON-REPRODUCIBLE, FALSE POSITIVE ACCUTNI RESULTS. THE CUSTOMER WAS UNABLE TO PROVIDE THE EXACT RESULTS OR DATES OF EVENTS. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1