BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1711100 · Received June 4, 2010

    Report

    Report Number
    1628664-2010-00230
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    April 28, 2010
    Report Date
    May 11, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT A PATIENT SAMPLE GENERATED ERRATIC SODIUM RESULTS ON THE ARCHITECT ANALYZER. SODIUM RESULTS OF 141, 139, 141, 118, 141, 140, AND 132 MMOL/L WERE GENERATED FROM THE SAME PATIENT SAMPLE. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1