BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2508115 · Received March 28, 2012

    Report

    Report Number
    1628664-2012-00193
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    March 4, 2012
    Report Date
    March 5, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CGZ
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONSEQUENCES OR IMPACT TO PATIENT; (B)(4): HIGH TEST RESULTS; (B)(4). THE EVALUATION IS IN PROGRESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPLACED THE SUSPECT ICT MODULE AND NO FURTHER ISSUES HAVE BEEN REPORTED. A REVIEW OF THE SYSTEM LOGS DID NOT VERIFY THE DISCREPANT RESULTS PROVIDED BY THE CUSTOMER OR IDENTIFY AN ISSUE WITH THE ICT MODULE. THE LOGS WERE NOT HELPFUL IN DETERMINING A LIKELY CAUSE FOR THE DISCREPANT RESULTS GENERATED. LABELING IN THE ARCHITECT SYSTEM OPERATIONS MANUAL AND ICT SAMPLE DILUENT PACKAGE INSERT IS ADEQUATE WITH REGARD TO REMOVING AND INSTALLING THE ICT MODULE AND THE ASSOCIATED PROBE AND TUBING, AND TROUBLESHOOTING THE CUSTOMER'S ISSUE. A REVIEW OF ICT MODULE HISTORICAL COMPLAINT AND TRENDING DATA DID NOT IDENTIFY AN ICT MODULE ISSUE AND/OR ATYPICAL COMPLAINT ACTIVITY. BASED ON THE AVAILABLE INFORMATION REVIEWED, AN ADVERSE TREND OF ISSUES AND/OR A DEFICIENCY OF THE ICT MODULE ARE NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THE ARCHITECT C8000 GENERATED AN ELEVATED ARCHITECT CHLORIDE OF 106 MEQ/L THAT REPEATED AT 94 MEQ/L ON A PATIENT SAMPLE. NO PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT MODULE LIST 9D28| SODIUM, CHLORIDE, ICT DILUENT LIST 2P32| ICT MODULE LIST 9D28 SODIUM, CHLORIDE| ICT DILUENT LIST 2P32