BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2073207 · Received April 29, 2011

    Report

    Report Number
    2122870-2011-01169
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 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
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER PRODUCT LINE SUPPORT (CPLS) IS CURRENTLY INVESTIGATING, REPORT RESULTS ARE PENDING. THERE IS NO INDICATION THAT SERVICE WAS SENT FOR THIS EVENT. TO DATE, NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) STATING THAT TOTAL HUMAN CHORIONIC GONADOTROPIN (TBHCG) QC DECREASES TOWARDS THE END OF THE REAGENT PACK . THE ISSUE HAS BEEN OCCURRING ON SEVERAL DIFFERENT REAGENT LOT NUMBERS. THE CUSTOMER HAS NOT SEEN ANY ERRONEOUS TBHCG PATIENTS' RESULTS. THE CUSTOMER HAS NOT RECEIVED ANY REPORTS OF ANY 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 JJE BECKMAN COULTER INC. ACCESS® 2 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1