BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1905060 · Received November 22, 2010

    Report

    Report Number
    2122870-2010-00740
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S REPEAT PROTOCOL IS TO RE-SPIN ALL UNEXPECTED RESULTS AND RERUN. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT DUE TO THE EVENT OCCURRING OVER 60 DAYS AGO. A ROOT CAUSE FOR THIS EVENT WAS NOT 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 INDICATED SOME OCCURRENCES OF NON-REPRODUCIBLE FALSE POSITIVE ACCUTNI PATIENT RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER WAS ASKED TO PROVIDE SPECIFIC DATA, HOWEVER, THE CUSTOMER DECLINED TO SUBMIT DATA DUE TO THE EVENT OCCURRING OVER 60 DAYS AGO. THE CUSTOMER DID NOT REPORT AFFECT TO THE PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

    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 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1