BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1052954 · Received May 27, 2008

    Report

    Report Number
    2122870-2008-00168
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 27, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM CHECK PERFORMED IN 2008 FAILED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED AIR IN THE WASH PUMP, A KINKED CABLE AND DEFECTIVE WASH PUMP. THE FSE REPLACED THE WASH PUMP AND MIXER MOTOR. THE FSE CORRECTED BACK PRESSURE IN THE WASTE LINE. THE FSE PERFORMED ACCU TNI BLANKS, LOW LEVEL PRECISION QC, AND PRECISION RUN WITH PATIENT SAMPLES; ALL RESULTS WERE WITHIN SPECIFICATIONS. THE FSE VERIFIED THE INSTRUMENT REPAIR PER ESTABLISHED PROCEDURES. HARDWARE ISSUES ADDRESSED BY THE FSE MAY HAVE CONTRIBUTED TO THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR THREE (3) PATIENT SAMPLES. INITIAL ACCU TNI RESULTS WERE 1.26 NG/ML, 4.64 NG/ML, AND 22.64 NG/ML FOR PATIENTS RESPECTIVELY. THE ORIGINAL SAMPLES WERE RE-TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND ACCU TNI RESULTS WERE: 0.02 NG/ML, 0.05 NG/ML, AND 0.06 NG/ML FOR OTHER PATIENTS RESPECTIVELY. IT IS UNCLEAR IF THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA