BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2475133 · Received March 2, 2012

    Report

    Report Number
    2050012-2012-00628
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 14, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT CALLED BACK TO REPORT ANY FURTHER ISSUES. THE ROOT CAUSE OF THE ISSUE IS NOT KNOWN; HOWEVER, THE QC VARIATION AND DOWNWARD TREND WERE NOT OF SUFFICIENT MAGNITUDE TO CAUSE AN OIR LO (OUT OF INSTRUMENT RANGE, LOW) RESULT. THEREFORE, THE ISSUE APPEARS TO HAVE BEEN ISOLATED TO THE ONE PATIENT SAMPLE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT QUALITY CONTROL (QC) RESULTS FROM THE UNICEL DXC 600 SYNCHRON SYSTEM WERE TRENDING LOW, AND THAT ONE PATIENT SAMPLE RECOVERED WITH A SUPPRESSED RESULT, OIR LO (OUT OF INSTRUMENT RANGE, LOW), FOR AMMONIA. CUSTOMER STATED THAT NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY; THEREFORE, PATIENT TREATMENT WAS NOT AFFECTED. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR ASSOCIATED WITH THIS COMPLAINT. THE FIELD SERVICE ENGINEER (FSE) FIRST INSPECTED THE INSTRUMENT FOR THE AMMONIA QC ISSUE ON (B)(4) 2012. NO REPORTS OF ANY ERRONEOUS PATIENT RESULTS ARE ASSOCIATED WITH THIS ISSUE. THE FSE REPLACED THE DEGASSER AND THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE. THE FSE RETURNED ON (B)(4) 2012, AND NOTED THAT SINCE THE REAGENT PROBES AND DEGASSER WERE REPLACED, INSTRUMENT PRECISION HAD FAVORABLY INCREASED. UPON THIS VISIT, IT WAS SUSPECTED THAT THE AMMONIA QC ERROR OCCURRED AS A RESULT OF A PREANALYTICAL ISSUE (POSSIBLE FIBRIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1