BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 1904815 · Received November 22, 2010

    Report

    Report Number
    2122870-2010-00756
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 16, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM THAT WERE COLLECTED OFF-SITE AND ARRIVED IN POUR-OFF TUBES. THE SAMPLES WERE RE-CENTRIFUGED PRIOR TO ANALYSIS. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES WITH AN OCCASIONAL HIGH OUTLIER. SERVICE WAS DISPATCHED ON (B)(6) 2010. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED A HIGH SENSITIVITY SYSTEM CHECK AND OTHER VERIFICATION TESTS. ALL TESTING RESULTS WERE WITHIN THE INSTRUMENT SPECIFICATIONS. THE FSE PERFORMED A ROUTINE SYSTEM CHECK AND THE RESULTS MET THE SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED TOTAL T3 (TT3) RESULTS WITHIN THE NORMAL REFERENCE RANGE GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER FOR THREE PATIENTS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED LOWER RESULTS IN A DIFFERENT CLINICAL CATEGORY FOR ALL THREE PATIENTS. 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 ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1