BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3631526 · Received February 18, 2014

    Report

    Report Number
    2050012-2014-00097
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE SEVERAL SERVICE VISITS TO THE SITE. THE FIELD SERVICE ENGINEERS (FSE) REPLACED MULTIPLE HARDWARE COMPONENTS AND PERFORMED MULTIPLE SERVICE TASKS TO RESOLVE THE ISSUE. ON (B)(4) 2014, A FIELD SERVICE ENGINEER (FSE) FOUND THE CAP PIERCER (255590) WAS NOT DISPENSING AUTO GLOSS AND ORDERED THE CAP PIERCER COMPLETE ASSEMBLY FOR REPLACEMENT. HE ALSO REPLACED REAGENT PROBE B (A15931) AND THE TRICONTINENT SYRINGE (A41599) FOR THE GLUCOSE CUP MODULE. ON (B)(4) 2014, ANOTHER FSE REPLACED THE CAP PIERCER (255590). THE FSE ALSO REPLACED BOTH OF THE SAMPLE PROBES (389375), THE 3 WAY T-VALVE (758419) AND THE HAMILTON A/B VALVE (970835). FINALLY, THE FSE VERIFIED THE SYSTEM PERFORMANCE AND THE ISSUE WAS RESOLVED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THEIR DXC600I INSTRUMENT GENERATED MULTIPLE ERRONEOUS RESULTS ON ONE PATIENT SAMPLE. THE ERRONEOUS RESULTS WERE NOT RELEASED TO THE PATIENT FILE, BUT THEY WERE VERBALLY REPORTED TO THE NURSING STATION. THE TECHNOLOGIST REALIZED THE RESULTS WERE NOT CORRECT AND CALLED THE NURSING UNIT BACK RIGHT AWAY. THE ERRONEOUS RESULTS DID NOT AFFECT PATIENT TREATMENT. OTHER SAMPLE RESULTS WERE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101358 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