BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1788276 · Received August 6, 2010

    Report

    Report Number
    2122870-2010-00413
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    June 15, 2010
    Report Date
    August 6, 2010
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WENT ON-SITE AND VERIFIED HARDWARE. NO HARDWARE ISSUES WERE NOTED. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY ELEVATED TESTOSTERONE, PROSTATE SPECIFIC ANTIGEN (PSA) AND SEX HORMONE BINDING GLOBULIN (SHBG) GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR SEVERAL PATIENTS. REPEAT TESTING PRODUCED LOWER RESULTS WITHIN A DIFFERENT CLINICAL CATEGORY. THE ACTUAL PATIENT RESULTS WERE NOT PROVIDED. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1