BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1811803 · Received August 23, 2010

    Report

    Report Number
    2050012-2010-00596
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIMENS ARE ROUTINELY DRAWN IN B-D SERUM SEPARATOR TUBES. PRIOR TO EACH EVENT, TPM WAS CALIBRATED AND QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. QC SAMPLES ARE ROUTINELY RUN EVERY 2 HOURS. THE INVESTIGATION WITH THE ASSISTANCE OF A TECHNICAL SUPPORT ENGINEER IS ONGOING. A ROOT CAUSE HAS NOT BEEN IDENTIFIED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN INTERMITTENT PROBLEM OF LOW MODULAR TOTAL PROTEIN (TPM) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. CUSTOMER INDICATED THAT ABOUT TWO LOW TPM FLYERS HAVE BEEN SEEN PER WEEK. THERE HAVE BEEN OCCASIONS WHERE FALSE LOW TPM RESULTS WERE REPORTED OUT OF THE LAB. WHEN DISCOVERED, SAMPLES HAVE BEEN REPEATED AND AMENDED REPORTS HAVE BEEN ISSUED. THE CUSTOMER HAS NOT RECEIVED ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1