BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2714579 · Received August 25, 2012

    Report

    Report Number
    2122870-2012-01709
    Event Type
    Malfunction
    Date Received
    August 25, 2012
    Date of Event
    July 31, 2012
    Report Date
    July 31, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 THREE DISCREPANT TROPONIN I (ACCUTNI) RESULTS. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT ACCESS ACCUTNI REAGENT, LOT 219417, AND ACCESS ACCUTNI CALIBRATORS (S0-S5), LOT 121451, WERE USED IN CONJUNCTION WITH THE DXC 600I SYSTEM. CUSTOMER REPORTED THAT THEY USED BIORAD QUALITY CONTROL (QC) LOT 23800, 23542 AND 23543. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND AIR BUBBLES IN THE WASH PUMP AND THE PIPETTOR TUBING DUE TO A WORN WASH PUMP TO MANIFOLD O-RING. THE FSE REPLACED THE O-RING AND THE BUBBLES CLEARED. THE FSE ALSO FOUND A WORN PIPETTOR PROBE, WORN ASPIRATE PROBES, AND A FLAT PERI-PUMP TUBING. THE FSE PROACTIVELY REPLACED THE PIPETTOR PROBE, THE ASPIRATE PROBES, AND THE PERI-PUMP TUBING. THE FSE THEN PERFORMED A SYSTEM CHECK AND A LOW LEVEL ACCUTNI QC PRECISION RUN AFTER REPLACEMENT OF THE PARTS. ALL RESULTS WERE WITHIN THE LABORATORY SPECIFICATIONS.

    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 75 YR