BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2222798 · Received August 25, 2011

    Report

    Report Number
    2122870-2011-02948
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 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
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE COLLECTED IN 5ML GREINER TUBES WITH GEL AND CENTRIFUGED FOR 10 MINUTES AT 3000 RPM AT ROOM TEMPERATURE. SPECIFIC SAMPLE TYPE HAS NOT BEEN SUPPLIED TO DATE. PER THE CUSTOMER, FRT QC HAD BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SPECIFIC QC DATA HAS NOT BEEN SUPPLIED TO DATE. ADDITIONAL SYSTEM ALSO HAS NOT BEEN SUPPLIED TO DATE. ALTHOUGH INTERMITTENT CABLE CONNECTION PROBLEMS MAY HAVE BEEN A CONTRIBUTING FACTOR, A DEFINITIVE 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 HIGHER THAN EXPECTED FREE THYROXINE (FRT4) RESULTS ABOVE THE NORMAL REFERENCE RANGE FOR TWO (2) PATIENTS' SAMPLES. THE RESULTS WERE GENERATED BY A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED LOWER RESULTS, ABOVE THE NORMAL REFERENCE RANGE BUT OUTSIDE OF THE ASSAY'S STATED PRECISION CLAIM OF LESS THAN OR EQUAL TO 10%. BOTH SAMPLES WERE ORIGINALLY RUN ON PIPETTOR 2 WHICH PREVIOUSLY HAD INTERMITTENT CABLE CONNECTION PROBLEMS. INITIAL FRT4 RESULTS WERE REPORTED OUT OF THE LAB. BOTH RESULTS WERE RECALLED AND CORRECTED. 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