BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2253328 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03453
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    May 7, 2008
    Report Date
    May 7, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE NOTED AN UNUSUAL BUILD UP OF DRIED WASH BUGGER WAS OBSERVED ON THE SAMPLE WASH TOWER. THE FSE CLEANED THE WASH BUFFER BUILD UP. THE FSE THEN PERFORMED REACTION VESSEL EXERCISER TEST TO OBSERVE ISSUES WITH WASH SPINNERS. NO ISSUES OBSERVED. ALSO, THE FSE PERFORMED A SYSTEM CHECK WHICH PASSED AND CHANGED THE ASPIRATE PROBES AND PERI PUMP TUBING. THEN THE FSE PERFORMED HIGH SENSITIVITY (HS) SYSTEM CHECK AND 40 REPLICATE PRECISION TESTS. BOTH TESTS MET SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES LIKELY CONTRIBUTED TO THIS EVENT, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. MDR# 2122870-2008-157 DOCUMENTS RESULTS FOR PATIENT #1. THIS IS 4 OF 10 SEPARATE MDR REPORTS RELATED TO 10 PATIENT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS MDR 2122870-2008-00157, 2122870-2011-03488, 03452, 03454, 03455, 03456, 03489, 03490, 03491 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 ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN I) RESULTS GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR 10 PATIENTS. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN RANGE. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PATIENT 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 ACCUTNI