BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2673501 · Received July 30, 2012

    Report

    Report Number
    2122870-2012-01638
    Event Type
    Malfunction
    Date Received
    July 30, 2012
    Date of Event
    July 2, 2012
    Report Date
    July 2, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ONE OF TWO REPORTS RELATED TO TWO EVENTS THAT OCCURRED ON TWO DAYS. THIS REPORT IS RELATED TO MDR# 2122870-2012-01637.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (DXC 600I) GENERATED DISCREPANT TROPONIN I (ACCUTNI) RESULTS ON THREE PATIENTS. CUSTOMER REPORTED THAT THE DISCREPANT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. CUSTOMER REPORTED THAT ACCESS ACCUTNI REAGENT, LOT 122056, AND ACCESS ACCUTNI CALIBRATORS (S0-S5), LOT 121451, WERE USED IN CONJUNCTION WITH THE DXC 600I ANALYZER. BEC FIELD SERVICE ENGINEER (FSE) PERFORMED TROUBLESHOOTING TO DETERMINE WHETHER THERE WERE HARDWARE ISSUES THAT NEEDED TO BE ADDRESSED. THE FSE PERFORMED SEVERAL REPAIRS TO THE INSTRUMENT INCLUDING REPLACING THE ASPIRATE PROBES, REPLACING THE PERI-PUMP TUBING, RE-TENSIONING THE INCUBATOR BELT AND REBUILDING THE WASH PUMP. THE FSE VERIFIED INSTRUMENT HARDWARE OPERATION WAS ACCEPTABLE AFTER ALL REPAIRS WERE COMPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR