BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2140233 · Received June 26, 2011

    Report

    Report Number
    2122870-2011-02036
    Event Type
    Malfunction
    Date Received
    June 26, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) OF OBTAINING INDETERMINATE (IND) FLAGS FOR CKMB, TSH AND TBHCG QC ALONG WITH OVR FLAGS FOR TT4 QC. THE ISSUE WAS DISCOVERED WHILE TROUBLESHOOTING WITH ACCESS HOTLINE. THERE WERE NO REAGENT PACKS ON BOARD. WHEN THIS OCCURS, THE INSTRUMENT DOES NOT DETECT THERE IS NO REAGENT PACK PRESENT.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1