BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2215524 · Received August 17, 2011

    Report

    Report Number
    2122870-2011-02896
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION WERE NOT SUPPLIED. QC ANALYSIS COULD NOT BE PERFORMED BECAUSE OF VERY LIMITED DATA DUE TO INSTRUMENT SETTING. ANALYSIS DID NOT TEND TO SHOW A REAGENT ISSUE. A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT WITH THE DATA SUPPLIED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING POSITIVE TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (T¿HCG) RESULTS THAT EXCEEDED THE ASSAY'S PRECISION CLAIMS FOR FIVE (5) PATIENTS. THE RESULTS WERE GENERATED BY A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH ACCESS T¿HCG REAGENT (LOT 170028) AND CALIBRATOR (LOT 022920). THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. 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 DHA BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1