BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 1953336 · Received January 8, 2011

    Report

    Report Number
    2122870-2011-00015
    Event Type
    Injury
    Date Received
    January 8, 2011
    Date of Event
    October 27, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLW
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE. DUE TO BELATED REPORTING OF THIS EVENT TO BCI, NO PATIENT SAMPLE IS AVAILABLE FOR INVESTIGATION. A DEFINITIVE 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 A NORMAL THYROID STIMULATING HORMONE (TSH) RESULT GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY, BUT WAS QUESTIONED BY THE PHYSICIAN AS NOT MATCHING THE PATIENT'S CLINICAL PRESENTATION. SUBSEQUENT TESTING BY ANOTHER METHODOLOGY PRODUCED A RESULT BELOW THE NORMAL REFERENCE RANGE. IT IS UNKNOWN IF THE PATIENT TREATMENT WAS AFFECTED IN THIS EVENT. THE RISK OF SERIOUS INJURY WILL BE ASSUMED UPON RECUR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other