BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 1064977 · Received June 24, 2008

    Report

    Report Number
    1628664-2008-00153
    Event Type
    Malfunction
    Date Received
    June 24, 2008
    Report Date
    June 4, 2008
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 CUSTOMER STATES THAT ONE PT SAMPLE GENERATED THE FOLLOWING RESULTS: SODIUM = 165 MMOL/L, POTASSIUM = 5.3 MMOL/L, CHLORIDE - 125 MMOL/L. THE RESULTS WERE FLAGGED WITH "HH" (OUTSIDE THE DEFINED EXTREME RANGE) AND THEREFORE RETESTED: SODIUM = 143/142 MMOL/L, POTASSIUM = 4.6/ 4.6 MMOL/L, CHLORIDE = 109/109 MMOL/L. OTHER ANALYTES TESTED SIMILAR BEFORE AND AFTER RETESTING. THE INITIAL SUSPECT RESULTS WERE NOT REPORTED FROM THE LAB. THERE IS NO IMPACT TO PT MGMT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AERO/C8K ICT MODULE LIST#: 9D28-03