BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2217987 · Received August 19, 2011

    Report

    Report Number
    2122870-2011-02958
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    April 13, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLW
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION DEVICE AND CENTRIFUGATION INFORMATION HAVE NOT BEEN SUPPLIED TO DATE. QC AND SYSTEM CHECK DATA HAVE NOT BEEN SUPPLIED TO DATE. BEC CUSTOMER PRODUCT LINE SUPPORT (CPLS) TESTING OF THE PATIENT'S SAMPLES CONFIRMED THE PRESENCE OF A PATIENT SOURCE INTERFERANT. PATIENT SAMPLE SOURCED INTERFERENCE IS THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING THYROID STIMULATING HORMONE (HTSH) RESULTS WITHIN OR SLIGHTLY ABOVE THE NORMAL REFERENCE RANGE FOR ONE (1) PATIENT THAT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE RESULT WAS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH ACCESS HYPERSENSITIVE HTSH REAGENT (LOT 170014). THE RESULT WAS ALSO DISCORDANT WITH RESULTS GENERATED BY THE LAB'S ALTERNATE METHOD FOR TESTING TSH. RESULTS GENERATED BY THE DXI 800 INSTRUMENT WERE NOT REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JLW BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1