BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY CARBON DIOXIDE

    MDR report key: 2595443 · Received June 1, 2012

    Report

    Report Number
    1628664-2012-00286
    Event Type
    Malfunction
    Date Received
    June 1, 2012
    Report Date
    May 16, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    KHS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CERTIFICATE OF ANALYSIS FOR CARBON DIOXIDE LOT 4148UQ08 WAS REVIEWED AND ALL FINAL RELEASE SPECIFICATIONS AND ACCEPTANCE CRITERIA WERE MET. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED RELATED TO THE COMPLAINT ISSUE. THE ARCHITECT CARBON DIOXIDE REAGENT PACKAGE INSERT AND THE ARCHITECT SYSTEM OPERATIONS MANUAL WERE REVIEWED AND WERE FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT LOW ARCHITECT CO2 RESULTS WERE GENERATED (7, 9 AND 8 MEQ/L) ON A PLASMA SAMPLE. BLOOD GAS RESULTS WERE 20 MEQ/L AND A SERUM SAMPLE FROM THE PATIENT GENERATED A RESULT OF 18 MEQ/L. THE PLASMA AND SERUM SAMPLES WERE RUN ON A SECOND ARCHITECT ANALYZER AND THEY PRODUCED THE SAME RESULTS (DATA WAS NOT PROVIDED). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY CARBON DIOXIDE KHS ABBOTT MANUFACTURING INC 41480UQ08

    Patients

    Seq Age Sex Outcome Treatment
    1 SN (B)(4)| ARCHITECT C4000ANALYZER 2P24-40| ARCHITECT C4000ANALYZER 2P24-40| SN (B)(4)