BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2200516 · Received August 11, 2011

    Report

    Report Number
    2122870-2011-02852
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION AND DEMOGRAPHICS WAS NOT PROVIDED. SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAS NOT BEEN PROVIDED. THE CUSTOMER ALWAYS ANALYZES BHCG IN DUPLICATES. THE CUSTOMER HAD A PASSING TBHCG CALIBRATION PERFORMED ON (B)(6) 2011. THE CUSTOMER HAD A PASSING SYSTEM CHECK PERFORMED ON (B)(6) 2011. ALL THREE LEVELS OF TBHCG QC WERE WITHIN THE ESTABLISHED RANGES ON THE DATE OF EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT WITH THE INFORMATION SUPPLIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) CONCERNING AN ERRONEOUSLY ELEVATED TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE TEST WAS PERFORMED IN DUPLICATE AND THIS ERRONEOUS RESULT CROSSED CLINICAL CATEGORIES. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED NEGATIVE RESULTS. THERE WAS NO REPORT 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 CLINICAL CHEMISTRY ANALYZER DHA BECKMAN COULTER, INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1