BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2190016 · Received August 4, 2011

    Report

    Report Number
    2122870-2011-02667
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAS NOT BEEN SUPPLIED TO DATE. PER THE CUSTOMER, TBHCG QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SPECIFIC QC DATA WAS NOT SUPPLIED TO DATE. THE CUSTOMER SENT THE PATIENT'S SAMPLE TO BEC CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING, WHICH PRODUCED NEGATIVE RESULTS ON TWO DIFFERENT LOTS OF TBHCG REAGENT. CPLS WAS UNABLE TO REPLICATE THE CUSTOMER'S ELEVATED TBHCG RESULTS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING REPRODUCIBLE FALSE POSITIVE TOTAL BETA HUMAN CHORIONIC GONADOTROPIN (THCG) FOR ONE (1) PATIENT. THE RESULTS WERE GENERATED BY A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, USED IN CONJUNCTION WITH ACCESS THCG REAGENT (LOT 071024). SUBSEQUENT TESTING OF THE PATIENT'S SAMPLE USING AN ALTERNATE METHODOLOGY GENERATED A "NEGATIVE" RESULT. 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 JJE BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR