BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 4130971 · Received October 1, 2014

    Report

    Report Number
    2050012-2014-00445
    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
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND EVALUATED THE INSTRUMENT. THE FSE REPLACED THE MC (MODULAR CUP) SAMPLE PROBE AND K (POTASSIUM) ELECTRODE TIP TO RESOLVE THE ISSUE. THE FSE VERIFIED INSTRUMENT OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING AN ERRONEOUSLY LOW K (POTASSIUM) RESULT FOR ONE PATIENT INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER REPEATED THE SAMPLE AND OBTAINED A HIGHER K RESULT. THE ERRONEOUSLY LOW K RESULT WAS REPORTED OUT OF THE LABORATORY AND LATER AMENDED. THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. QUALITY CONTROL WAS WITHIN LAB ESTABLISHED RANGES ON THE DAY OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612966 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