BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2032868 · Received March 29, 2011

    Report

    Report Number
    2122870-2011-00762
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS COLLECTED IN A BD LITHIUM HEPARIN PLASMA TUBE WITH GEL. SERVICE WAS NOT DISPATCHED, AS CUSTOMER IS NOT QUESTIONING INSTRUMENT PERFORMANCE. NO CLEAR ROOT CAUSE HAS BEEN DETERMINED FOR THIS EVENT.

    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 TROPONIN (ACCUTNI) RESULT. THE CUSTOMER WAS UNABLE TO PROVIDE THE EXACT RESULT OR DATE OF THE EVENT. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB. PATIENT WAS TRANSFERRED TO THE MAIN HOSPITAL, REDRAWN AND RECOVERED NORMAL ACCUTNI RESULT. THERE WAS NO DEATH OR INJURY IN CONNECTION TO THIS EVENT.

    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 Hospitalization