BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1083894 · Received July 28, 2008

    Report

    Report Number
    2122870-2008-00231
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 4, 2008
    Report Date
    July 28, 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
    TN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, QC WAS WITHIN EXPECTED RANGE THE DAY OF EVENT. MAINTENANCE AND SYSTEM CHECK HAD BEEN PERFORMED EARLIER THAT SHIFT WITH ALL PARAMETERS WITHIN SPECIFICATIONS. PER CUSTOMER, THEY TEND TO HAVE A PROBLEM WITH FIBRIN IN THE SPECIMENS COLLECTED IN THE ER AND PLANS TO EDUCATE THE ER STAFF ON PROPER SAMPLE HANDLING TECHNIQUES. A FIELD SERVICE ENGINEER (FSE) WAS NOT SENT FOR THIS EVENT. NO ADDITIONAL INFO REGARDING THIS EVENT IS AVAILABLE TO DATE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. 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 THAT WERE GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR A SINGLE PT SAMPLE. AN INITIAL ACCU TNI RESULT OF 6.85NG/ML WAS REPORTED OUT OF THE LAB AND QUESTIONED BY THE PHYSICIAN. THE ORIGINAL SAMPLE WAS RE-TESTED AND REPEATED ACCU TNI RESULTS WERE 0.90NG/ML AND 0.28NG/ML. THE SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND TWO RESULTS OF 0.46 NG/ML WERE OBTAINED. CORRECTED REPORT WAS SENT. THERE HAVE BEEN NO REPORTS OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT 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 DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA