BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1282031 · Received December 24, 2008

    Report

    Report Number
    2122870-2008-00426
    Event Type
    Other
    Date Received
    December 24, 2008
    Date of Event
    December 15, 2008
    Report Date
    December 24, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION DATA WAS NOT SUPPLIED. QC WAS WITHIN SPECIFICATIONS PRIOR TO THE EVENT. BASED ON AVAILABLE INFORMATION, THE FSE PROGRAMMED A DIAGNOSTIC TESTING VIA PRO SERVICE WHICH THE CUSTOMER RAN. THE FSE ANALYZED THE RESULTS AND THE TESTING PASSED. NO ADDITIONAL INFORMATION REGARDING SERVICE WAS SUPPLIED TO DATE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI), REGARDING AN ERRONEOUSLY HIGH TROPONIN (ACCU TNI) RESULT GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. A SAMPLE FROM A PATIENT GAVE AN ACCU TNI RESULT OF 4.52NG/ML. THE RESULT WAS NOT REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLE WAS RE-TESTED AND REPEATED RESULT WAS 0.02NG/ML. THERE WAS NO EFFECT TO PATIENT TREATMENT IN CONNECTION 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA