BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 4131015 · Received October 1, 2014

    Report

    Report Number
    2050012-2014-00451
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND EVALUATED THE DEVICE. THE FSE FOUND THE CAUSE OF THE LEAK WAS THE COLLAR WASH VALVE. THE FSE REPLACED THE VALVE TO RESOLVE THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNICEL DXC 600I SYNCHRON SYSTEM HAD A FLUID LEAK COMING FROM THE CHEMISTRY CARTRIDGE (CC) SAMPLE PROBE. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT AND DID NOT LEAK ON TO THE FLOOR. THERE WAS NO REPORT OF INJURY; NO ERRONEOUS PATIENT RESULTS WERE GENERATED ASSOCIATED WITH THIS EVENT. THE CUSTOMER WAS WEARING LAB COAT, GLOVES AND EYE PROTECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612505 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1