BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1183384 · Received October 3, 2008

    Report

    Report Number
    1628664-2008-00229
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). ABBOTT FIELD SERVICE WAS DISPATCHED TO THE ACCOUNT AND FOUND ICT REFERENCE SOLUTION LEAKING FROM THE ASPIRATION LINE AND A STICKY ICT ASPIRATION SYRINGE. FIELD SERVICE RESOLVED THE CUSTOMER ISSUE ON SITE BY CLEANING AND REPLACING THE ICT ASPIRATION SYRINGE FOLLOWED BY A PASSING CALIBRATION AND ACCEPTABLE QC. LABELLING IN THE ARCHITECT OPERATIONS MANUAL LN 06E28-07 ((B)(4) 2007) PROVIDES SUFFICIENT INFORMATION WITH REGARD TO SYSTEM MAINTENANCE AND TROUBLESHOOTING THE CUSTOMER'S ISSUE. TROUBLESHOOTING PERFORMED BY FIELD SERVICE TO RESOLVE THE ISSUE WAS CONSISTENT WITH TROUBLESHOOTING INFORMATION IN THE ARCHITECT OPERATIONS MANUAL. NO DEFICIENCY WAS IDENTIFIED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT C8000 ANALYZER GENERATED THE FOLLOWING RESULTS ON A PATIENT: SODIUM = 107 MMOL/L, POTASSIUM = 2.8 MMOL/L, AND CHLORIDE = 141 MMOL/L. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER WITH THE FOLLOWING RESULTS: SODIUM = 144 MMOL/L, POTASSIUM = 3.8 MMOL/L, AND CHLORIDE = 104 MMOL/L. THE RESULTS WERE NOT REPORTED AND THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AERO/C8K ICT MODULE LIST#: 9D28-03| AERO/C8K ICT MODULE LIST#: 9D28-03