BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1992234 · Received February 15, 2011

    Report

    Report Number
    2122870-2011-00385
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 18, 2010
    Report Date
    January 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE IS LITHIUM HEPARIN PLASMA COLLECTED IN A PST TUBE. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. THE INSTRUMENT IS CURRENTLY PERFORMING AS EXPECTED. A TECH HAD PROGRAMMED THE INSTRUMENT TO LOAD A TROPONIN REAGENT PACK AND HAD NOT PHYSICALLY LOADED THE TROPONIN PACK, SO NO PACK WAS PRESENT AT THE POSITION THE REAGENT INVENTORY INDICATED. USE ERROR IS THE ROOT CAUSE FOR HIS 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 INDICATED THAT APPROXIMATELY A MONTH AGO A TROPONIN (ACCUTNI) REAGENT PACK WAS MISLOADED AND THEREFORE IN THE INCORRECT SLOT OF THE REAGENT STORAGE CAROUSEL. THE CUSTOMER WAS ASKED TO PROVIDE SPECIFIC DATA; HOWEVER, THE CUSTOMER DECLINED TO SUBMIT DATA DUE TO ELAPSED TIME SINCE EVENT OCCURRENCE. THE CUSTOMER DID NOT KNOW IF THERE WERE ANY REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH 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