BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000 ANALYZER

    MDR report key: 3910456 · Received July 2, 2014

    Report

    Report Number
    1628664-2014-00131
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A FALSELY ELEVATED CO2 RESULT WAS GENERATED BY THE ARCHITECT C4000 ANALYZER. AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE ASPIRATION TUBING BUNDLE TO RESOLVE THE ISSUE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT C4000 ANALYZER GENERATED AN ELEVATED CO2 RESULT OF 37.4 MEQ/L. THE SAMPLE WAS REPEATED AND A RESULT OF 25.4 MEQ/L WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388324 ARCHITECT C4000 ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1