BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1173048 · Received September 19, 2008

    Report

    Report Number
    2122870-2008-00293
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 19, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS IN RANGE BEFORE THE EVENT. A SYSTEM CHECK PERFORMED IN 2008 PASSED. NO FLAGS OR EVENT LOG MESSAGES WERE GENERATED AT THE TIME OF THE EVENT. THE SPECIMEN WAS COLLECTED IN A GREINER 13X100MM SERUM TUBE WITH GEL SEPARATOR AND WAS CENTRIFUGED AT 3,400 RPM FOR 10 MINUTES. THE SAMPLE WAS RUN IMMEDIATELY AFTER PROCESSING. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND ALL HARDWARE VERIFICATION PASSED. AN APPLICATION SPECIALIST CHECKED SAMPLE INTEGRITY AND VERIFIED APPROPRIATE SAMPLE HANDLING. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. 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 AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT THAT WAS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR A SINGLE PATIENT SAMPLE. AN ACCU TNI RESULT OF 0.65NG/ML WAS REPORTED OUT OF THE LAB. THE RESULT WAS QUESTIONED BY A PHYSICIAN. THE ORIGINAL SAMPLE WAS RETESTED AND A RESULT OF 0.011 NG/ML WAS OBTAINED. A CORRECTED REPORT WAS SENT. THERE WAS NO EFFECT TO THE PATIENT AS A RESULT OF 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