BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2803238 · Received October 24, 2012

    Report

    Report Number
    1628664-2012-00462
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MZV
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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

    SERVICE WAS DISPATCHED TO THE ACCOUNT. AS A PRECAUTION, SYRINGES AND VALVES WERE REPLACED AND THE SYSTEM WAS THOROUGHLY FLUSHED. ADDITIONAL STUDIES FOUND NO ISSUES. CALIBRATION AND QC DATA WERE OK. 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 DEFICIENCY/MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT C8000 ANALYZER GENERATED A POTASSIUM RESULT OF 6.7 MMOL/L. THE SAMPLE WAS REPEATED 2 TIMES WITH RESULTS OF 4.3 MMOL/L. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM MZV ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT MODULE 9D28-03| ICT MODULE 9D28-03