BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 1914703 · Received December 3, 2010

    Report

    Report Number
    2122870-2010-00857
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM CHECKS MET THE SPECIFICATIONS. A BCI CUSTOMER PRODUCT LINE SUPPORT (CPLS) RECEIVED THREE SAMPLES FROM THE PATIENT IN QUESTION. THE SAMPLES WERE CENTRIFUGED PRIOR TO TESTING. THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE AND REPRODUCIBLE. THE INVESTIGATION DID NOT DEMONSTRATE AN INTERFERENCE OR REAGENT ISSUE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A CLEAR ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ELEVATED THYROID STIMULATING HORMONE (HTSH) RESULT ABOVE THE NORMAL REFERENCE RANGE GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING ON THE SAME AND A SUBSEQUENT SAMPLE PRODUCED RESULTS IN THE NORMAL REFERENCE RANGE. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1