BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2223199 · Received August 12, 2011

    Report

    Report Number
    2122870-2011-02793
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    August 2, 2008
    Report Date
    August 4, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE PERFORMED HIGH SENSITIVITY (HS) SYSTEM CHECK AND CARRYOVER DIAGNOSTIC TEST. ALL TEST PASSED. THE FSE COMPLETED UPPER REAGENT PUMP SPRING MOD. THEN THE FSE PERFORMED 20 REPLICATE PRECISION RUN USING LOW LEVEL QUALITY CONTROLS (QC) AND THE RESULTS WERE ACCEPTABLE. THE FSE ALSO TESTED 2 SEPARATE PT SAMPLES WITH GOOD REPRODUCIBILITY. WHILE PRE-ANALYTICAL FACTORS MAY BE A CONTRIBUTING FACT, A CLEAR ROOT CAUSE CANNOT BE DETERMINED FOR THIS EVENT. THIS IS 16 OF 20 SEPARATE MDR REPORTS RELATED TO 20 PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS: 2122870-2011-02778, 02779, 02780, 02781, 0282. 02783. 02784, 02785, 02786, 02787, 02788, 02789, 02790, 02791, 02792, 02794, 02795, 02796, 02797 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 THROUGH OCTOBER 23, 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCU TNI (TROPONIN I) AND CK-MB RESULTS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR SEVERAL PTS. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LAB. THE CUSTOMER ONLY REPORTED RESULTS FOR THREE PTS. ONLY ONE PT HAD ELEVATED CK-MB RESULT THE OTHER PTS HAD ELEVATED ACCU TNI RESULTS. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE IN A DIFFERENT CLINICAL CATEGORY. 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS CK-MB| ACCESS ACCU TNI