BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1065950 · Received June 25, 2008

    Report

    Report Number
    2122870-2008-00201
    Event Type
    Other
    Date Received
    June 25, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DRAWN IN PLASTIC GREINER VACUTAINER TUBE AND CENTRIFUGED AT 2200 G FOR 15 MINS. FIELD SERVICE ENGINEER (FSE) WAS ONSITE IN 2008: FSE FOUND AN INCUBATOR BELT JAM AND MULTIPLE BROKEN RV CLIPS. FSE REPLACED CLIPS AND INCUBATOR BELT. FSE REPLACED THE ASPIRATE PROBES AND RAN SYSTEM CHECK WHICH WAS WITHIN SPECS. 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 ACCU TNI RESULT GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PT. CUSTOMER TESTED A SAMPLE FOR ACCU TNI AND OBTAINED A RESULT OF 6.50 NG/ML. THE SAMPLE WAS RE-SPUN AND RE-TESTED AND GAVE A RESULT OF 0.02 NG/ML. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. CUSTOMER MADE NO REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA