BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2083723 · Received May 10, 2011

    Report

    Report Number
    2122870-2011-01348
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 10, 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 SAMPLE WAS COLLECTED IN GREINER VACUETTE SERUM TUBE AND WAS CENTRIFUGATED AT 3000G FOR 10 MINUTES AT 20 DEGREES CELSIUS. PER CUSTOMER, THE SAMPLE APPEARED CLEAR. ALTHOUGH, THE SAMPLE APPEARED CLEAR, CUSTOMER WAS NOT SATISFIED WITH THE QUALITY OF SEPARATION THEY ARE GETTING FROM THE GREINER TUBES. QC AND SYSTEM CHECK DATA WERE NOT SUPPLIED BY CUSTOMER. A BCI APPLICATIONS SPECIALIST ASSESSED SYSTEM PERFORMANCE AND FOUND NO INSTRUMENT ISSUE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT 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 ACCUTNL RESULT GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE INITIAL SAMPLE AND A SUBSEQUENT SAMPLE WERE REPEATED AND RUN ON THE SAME INSTRUMENT. 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 72 YR