BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2374943 · Received December 14, 2011

    Report

    Report Number
    2050012-2011-08354
    Event Type
    Malfunction
    Date Received
    December 14, 2011
    Date of Event
    November 22, 2011
    Report Date
    November 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE UNICEL DXC 800 SYNCHRON SYSTEM GENERATED MULTIPLE SUPPRESSED CHEMISTRY CARTRIDGE RESULTS, SPECIFICALLY AN OIR LO (OUT OF INSTRUMENT RANGE, LOW) ERROR CODE FOR GLUCOSE RESULTS, AND RXN RATE LOW (REACTION RATE, LOW) AND OIR LO ERROR CODES FOR URINE DRUGS OF ABUSE RESULTS. (PLEASE NOTE THAT OIR LO IS NOT A POSSIBLE ERROR CODE FOR URINE DRUGS OF ABUSE SCREENS; IT IS POSSIBLE THAT CUSTOMER OBSERVED INITIAL RATE LOW OR BLANK RATE LOW ERRORS, WHICH COULD NOT BE REPORTED OUTSIDE THE LABORATORY.) CUSTOMER STATED THAT NO PATIENT RESULTS WERE REPORTED; THEREFORE, PATIENT TREATMENT WAS NOT AFFECTED. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT THE REAGENT SYRINGE WAS LOOSE AND LEAKING. THE FSE THEN TIGHTENED AND RAN THE PROBE CLEANING, WHICH WAS FAILING, BUT PASSED AFTER SERVICE. FINALLY, THE FSE VERIFIED INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE. THE FSE COULD NOT DETERMINE THE ROOT CAUSE, BUT SUSPECTS THAT THE INSTRUMENT ISSUE WAS DUE TO A HARDWARE FAILURE. CUSTOMER STATED THAT NO ONE WAS HARMED BY THE INSTRUMENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1