BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 3030936 · Received April 2, 2013

    Report

    Report Number
    1628664-2013-00077
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CGZ
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RESOLVED THE ISSUE BY REPLACING THE ICT MODULE. THE CUSTOMER'S SERVICE HISTORY DOES NOT INCLUDE A RECURRENCE OF ERRATIC / DISCREPANT ICT ASSAY RESULTS. EXAMINATION OF THE CUSTOMER RETURNED ICT MODULE REVEALED THAT THE BOTTOM ICT O-RING WAS MIS-ALIGNED AND DAMAGED. THE PHYSICAL EVIDENCE SUPPORTS THAT THE ICT MODULE O-RINGS WERE NOT SEATED CORRECTLY DURING INSTALLATION AND WERE DAMAGED POSSIBLY BY OVER-TIGHTENING THE CONNECTIONS. OVER TIGHTENING THE ICT O-RING CONNECTIONS CAN TWIST THE O-RINGS AND/OR OBSTRUCT FLOW THROUGH THE ICT MODULE. REVIEW OF ICT MODULE HISTORICAL COMPLAINT AND TRENDING DATA DID NOT IDENTIFY AN ADVERSE TREND. LABELING IN THE ARCHITECT SYSTEM OPERATIONS MANUAL AND ICT SAMPLE DILUENT PACKAGE INSERT IS ADEQUATE WITH REGARD TO REQUIRED MAINTENANCE, COMPONENT REPLACEMENT, MATERIAL HANDLING, AND TROUBLESHOOTING THE CUSTOMER'S ISSUE. BASED ON THE AVAILABLE INFORMATION AND THE EXAMINATION OF RETURNED ICT MODULE, THE MOST LIKELY PROBABLE CAUSE IDENTIFIED FOR THE CUSTOMER'S ISSUE IS OVER TIGHTENED AND/OR INCORRECTLY SEATED ICT O-RINGS. THE AVAILABLE INFORMATION DOES NOT REASONABLY INDICATE A MALFUNCTION OF THE ICT MODULE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED SPORATIC ELEVATED CHLORIDE RESULTS FOR PATIENT SAMPLES TESTED ON THE ARCHITECT C8000 ANALYZER. THE CUSTOMER PROVIDED INITIAL AND REPEAT RESULTS FOR FIVE PATIENTS. THE REPEAT RESULTS WERE GENERATED ON A DIFFERENT ARCHITECT C8000 ANALYZER. THE ICT MODULE (SERIAL NUMBER (B)(4)) ON C8000 SERIAL NUMBER (B)(4) WAS REPLACED TO RESOLVE THE ISSUE. THIS EMDR IS FOR PATIENT #2 OF FIVE. AN INITIAL RESULT OF 115 MMOL/L REPEATED AT 105 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135251 ARCHITECT C8000 SYSTEM CGZ ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR ICT MODULE, LIST 09D28-03, SERIAL (B)(4)| ICT MODULE, LIST 09D28-03, SERIAL (B)(4)