BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 1953337 · Received January 8, 2011

    Report

    Report Number
    2122870-2011-00017
    Event Type
    Malfunction
    Date Received
    January 8, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 9, 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

    QC WAS WITHIN THE ESTABLISHED RANGES. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE. THE PATIENT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION BY BCI. ALTHOUGH A PATIENT SOURCE INTERFERENT IS CONSIDERED A LIKELY ROOT CAUSE, 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 AN ERRONEOUSLY ELEVATED THYROID STIMULATING HORMONE (HTSH) RESULT ABOVE THE NORMAL REFERENCE RANGE GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING ON THE SAMPLE AFTER TREATED WITH A HBT (HETEROPHILE BLOCKING TUBE) PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE. SUBSEQUENT TESTING BY ANOTHER METHODOLOGY PRODUCED A RESULT BELOW THE NORMAL REFERENCE RANGE. IT IS UNKNOWN WHICH RESULT WAS DETERMINED TO BE CORRECT. THERE WAS NO EFFECT TO THE PATIENT TREATMENT BASED ON THE ERRONEOUSLY ELEVATED RESULT.

    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