BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 1649346 · Received April 2, 2010

    Report

    Report Number
    2122870-2010-00120
    Event Type
    Malfunction
    Date Received
    April 2, 2010
    Date of Event
    February 25, 2010
    Report Date
    April 2, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MXZ
    PMA / PMN Number
    K922826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND SYSTEM PERFORMANCE INFORMATION WAS NOT SUPPLIED.SERVICE WAS NOT DISPATCHED FOR THIS EVENT.A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED LOWER THAN EXPECTED RESULTS FOR PROGESTERONE ON TWO (2) PATIENTS' SAMPLES. A) THE RESULTS WERE REPORTED OUT OF THE LAB. B) ONE PATIENT WAS TREATED WITH PROGESTERONE AND SUBSEQUENT TESTING STILL RESULTED LOW. C) THE SECOND PATIENT'S SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND RECOVERED HIGHER RESULTS THAT FIT THE PATIENT'S CLINICAL PICTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MXZ BECKMAN COULTER INC. ACCESS® IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1