BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2253300 · Received September 9, 2011

    Report

    Report Number
    2122870-2011-03449
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    January 9, 2009
    Report Date
    January 9, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2009, INVESTIGATING THE EVENT. THE FSE RAN HIGH SENSITIVITY (HS) SYSTEM CHECK WHICH MET SPECIFICATIONS. FURTHER INVESTIGATION WITH THE CUSTOMER CONFIRMED CLOUDY SAMPLES INDICATING THE SAMPLE CONTAINED CELLULAR DEBRIS. PRE-ANALYTICAL SAMPLE HANDLING IS THE ROOT CAUSE FOR THIS EVENT. THIS IS A SINGLE EVENT INVOLVING TWO PT SAMPLES. THERE WERE NO REPORTS OF ANY ADVERSE EVENT, CHANGES TO 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 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 ERRONEOUS RESULTS FOR ACCUTNI (TROPONIN I) AND CK-MB FOR TWO PTS. THE RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. 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

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2009, INVESTIGATING THE EVENT. THE FSE RAN HIGH SENSITIVITY (HS) SYSTEM CHECK WHICH MET SPECIFICATIONS. FURTHER INVESTIGATION WITH THE CUSTOMER CONFIRMED CLOUDY SAMPLES INDICATING THE SAMPLE CONTAINED CELLULAR DEBRIS. PRE-ANALYTICAL SAMPLE HANDLING IS THE ROOT CAUSE FOR THIS EVENT. THIS IS A SINGLE EVENT INVOLVING TWO PT SAMPLES. THERE WERE NO REPORTS OF ANY ADVERSE EVENT, CHANGES TO 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 JANUARY 1, 2008 THROUGH OCTOBER 23, 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 2

    THE CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) IN REGARDS TO ERRONEOUS RESULTS FOR ACCUTNI (TROPONIN I) AND CK-MB FOR TWO PTS. THE RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. 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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR ACCESS ACCESS CK-MB| ACCESS ACCUTNI
    2 53 YR ACCESS CK-MB| ACCESS ACCUTNI