BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 3641235 · Received February 24, 2014

    Report

    Report Number
    2050012-2014-00098
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND REPLACED THE HAMILTON 4-4 VALVE AND T-VALVE WHICH RESOLVED THE ISSUE. IDENTIFIED FAILURE MODE: FSE CONFIRMED FAILURE MODE TO BE THE HAMILTON 4-4 VALVE PN 970835 AND T-VALVE PN 758419. (B)(4).

    Description of Event or Problem · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) IDENTIFIED A LEAK WHEN SERVICING A UNICEL® DXC 600 SYNCHRON® SYSTEM AT A CUSTOMER'S FACILITY. THERE WAS LEAKING FROM THE REAGENT T VALVE AND 4 WAY VALVE AND DRIPPING FROM THE PROBE ON THE INSTRUMENT. THERE WAS NO REPORT OF OPERATOR EXPOSURE OR INJURY. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113021 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1