BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2161052 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01886
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    February 6, 2009
    Report Date
    February 9, 2009
    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

    SERVICE WAS NOT SENT OUT FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) DID NOT EVALUATE THE DEVICE. ALTHOUGH THE CUSTOMER CONSIDERS INSUFFICIENT CLOTTING TIME OF THE SAMPLE OCCURRED, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) REGARDING ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN) RESULT, WITHIN THE RISK STRATIFICATION RANGE, FOR ONE PATIENT. THE RESULT WAS GENERATED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE INITIAL ERRONEOUSLY ELEVATED RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER RE-RAN THE SAMPLE AND IT WAS WITHIN THE NORMAL REFERENCE RANGE. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR CHANGE TO THE PATIENTS' TREATMENT. THERE ARE NO INDICATIONS OF 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 77 YR ACCESS ACCUTNI