BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2351655 · Received November 18, 2011

    Report

    Report Number
    2122870-2011-05394
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    September 23, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN APPLICATION SPECIALIST WAS SENT TO THE SITE ON (B)(4) 2008, TO INVESTIGATE THE EVENT. THE APPLICATION SPECIALIST PERFORMED HARDWARE VERIFICATION TO INCLUDE RUNNING SYSTEM CHECK, LUMWASH SON/INC., HIGH SENSITIVITY (HS) SYSTEM CHECK, CTA CARRYOVER PERFORMANCE VERIFICATION TESTING, AND QUALITY CONTROL (QC) FOR ALL ENABLED ASSAYS. ALL TESTING MET SPECIFICATIONS. INSTRUMENT VERIFICATION TESTING NOTED INSTRUMENT PERFORMING WITHIN SPECIFICATIONS. THE APPLICATIONS SPECIALIST PERFORMED VISUAL INSPECTION OF QUESTIONED PATIENT SAMPLES. ALL SPECIMENS WERE NOTED TO BE SERUM, CLEAR, AND FREE OF DEBRIS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. MDR # 2122870-2008-328 DOCUMENTS THE RESULTS FOR PATIENT 1. THIS IS 2 OF 3 SEPARATE MDR REPORTS RELATED TO 5 PATIENT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT ON DIFFERENT DAYS. REFERENCE MDR NUMBERS: 2122870-2008-328, 2122870-2011-05394, 2122870-2011-05395 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 THOUGH OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) REGARDING ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN) RESULT IN THE RISK STRATIFICATION RANGE FOR FIVE PATIENTS ON DIFFERENT DAYS. THE RESULT WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER RE-RAN THE SAMPLE ON ANOTHER INSTRUMENT AND THE RESULTS WERE WITHIN THE REFERENCE RANGE AND AMENDED REPORTS WERE SENT OUT OF THE LABORATORY. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PATIENT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI