BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT C8000

    MDR report key: 656791 · Received December 23, 2005

    Report

    Report Number
    1628664-2005-00052
    Event Type
    Other
    Date Received
    December 23, 2005
    Date of Event
    November 30, 2005
    Report Date
    December 21, 2005
    Manufacturer
    ABBOTT MANUFACTURING, INC
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED DISCREPANT ARCHITECT C8000 POTASSIUM RESULTS. A PATIENT SAMPLE THAT INITIALLY TESTED AT 7.9 MMOL/L RETESTED AT 4.1 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN