BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2152334 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-01937
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    December 1, 2008
    Report Date
    December 16, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE PERFORMED THE CARRYOVER TEST AND IT FAILED. THE FSE REPLACED THE TIPS ON REAGENT PIPETTORS 2 AND 3. IT IS UNK WHICH PIPETTOR WAS USED FOR EACH RESULT REPORTED. THE CARRYOVER PROCEDURE WAS REPEATED BY THE FSE AND THE RESULTS PASSED WITHIN SPECIFICATIONS. ALTHOUGH THE FSE ADDRESSED SEVERAL HARDWARE ISSUES, NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT. THIS IS THREE OF THREE SEPARATE MDR REPORTS RELATED TO THREE PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT ON DIFFERENT DAYS. REFERENCE MDR NUMBERS 2122870-2011-01935, 2122870-2011-01936 FOR ALL EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ELEVATED ACCU TNI (TROPONIN I) RESULTS OBTAINED FROM A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR THREE PTS. THE CUSTOMER RE-CENTRIFUGED AND RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN NORMAL REFERENCE RANGE. THE CUSTOMER ONLY PROVIDED THE DATA FOR ONE PT. THE INITIAL ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PT TREATMENT. THERE IS NO INDICATION OF AN ADVERSE EVENT OR INDICATION OF ANY MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI