BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2083638 · Received May 10, 2011

    Report

    Report Number
    2122870-2011-01349
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN A GREINER VACUETTE SERUM 13MM X 100MM TUBE AND WAS CENTRIFUGATED AT 3050G FOR 10 MINUTES AT 18º CELSIUS. PER CUSTOMER: THE SAMPLE WAS A FULL DRAW. NO ISSUES WITH SYSTEM CHECKS OR FLAGS WERE NOTED. A BCI APPLICATION SPECIALIST WAS DISPATCHED AND ASSESSED SYSTEM PERFORMANCE. NO FINDINGS WERE AVAILABLE FROM THE SPECIALIST'S VISIT. NO CLEAR ROOT CAUSE FOR THIS EVENT HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A NON-REPRODUCIBLE ERRONEOUS POSITIVE ACCUTNI RESULT GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE RESULT WAS SUBMITTED OUT OF THE LABORATORY. THE INITIAL SAMPLE WAS REPEATED AND A SUBSEQUENT SAMPLE WAS TESTED ON THE SAME INSTRUMENT AND RESULTS WITHIN THE NORMAL REFERENCE RANGE WERE OBTAINED. 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 CLINICAL CHEMISTRY SYSTEMS MMI BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1