BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2395351 · Received January 3, 2012

    Report

    Report Number
    2050012-2011-08518
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    December 7, 2011
    Report Date
    December 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (600I) GENERATED CARTRIDGE CHEMISTRY (CC) CUVETTE NOT DRY BEFORE FIRST REAGENT DETECTION ERROR. CUSTOMER REPORTED THAT THE REAGENT PROBE WAS LEAKING. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND PROBE B LEAKED DURING QUALITY CONTROL RUN. THE FSE REPLACED THE REAGENT PROBE B WASTE VACUUM VALVE. THE REPLACEMENT OF THE VALVE RESOLVED THE ISSUE. THE FSE ALSO REPLACED ALL CC REAGENTS. THE FSE RECALIBRATED ALL CC CHEMISTRIES AND RAN QUALITY CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1