BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2172501 · Received June 24, 2011

    Report

    Report Number
    2122870-2011-01944
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    April 16, 2008
    Report Date
    April 16, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 A LUMWASH AND PRECISION TESTING WHICH PASSED WITHIN SPECIFICATION. ALTHOUGH THE ROOT CAUSE OF THE EVENT IS UNK, SAMPLE HANDLING MAY BE POSSIBLE CONTRIBUTORY CAUSES TO THIS EVENT. THIS IS A SINGLE EVENT INVOLVING MULTIPLE PT SAMPLES. THERE WERE NO REPORTS OF ANY ADVERSE EVENT, CHANGES IN PT CARE OR ANY INDICATION THAT MEDICAL INTERVENTION WAS NEEDED TO PREVENT OR PRECLUDE ADVERSE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JAN 1, 2008 AND OCT 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) REGARDING ELEVATED ACCUTNI (TROPONIN I ) RESULT IN THE RISK STRATIFICATION RANGE FOR TWO PTS. THE RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER RE-RAN THE SAMPLE ON ANOTHER INSTRUMENT AND IT WAS WITHIN THE REFERENCE RANGE. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LAB. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.

    Additional Manufacturer Narrative · 2

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE PERFORMED A LUMWASH AND PRECISION TESTING WHICH PASSED WITHIN SPECIFICATION. ALTHOUGH THE ROOT CAUSE OF THE EVENT IS UNK, SAMPLE HANDLING MAY BE POSSIBLE CONTRIBUTORY CAUSES TO THIS EVENT. THIS IS A SINGLE EVENT INVOLVING MULTIPLE PT SAMPLES. THERE WERE NO REPORTS OF ANY ADVERSE EVENT, CHANGES IN PT CARE OR ANY INDICATION THAT MEDICAL INTERVENTION WAS NEEDED TO PREVENT OR PRECLUDE ADVERSE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JAN 1, 2008 AND OCT 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 2

    THE CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) REGARDING ELEVATED ACCUTNI (TROPONIN I) RESULT IN THE RISK STRATIFICATION RANGE FOR TWO PTS. THE RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER RE-RAN THE SAMPLE ON ANOTHER INSTRUMENT AND IT WAS WITHIN THE REFERENCE RANGE. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LAB. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR ACCESS ACCUTNI
    2 84 YR ACCESS ACCUTNI