BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1905117 · Received November 22, 2010

    Report

    Report Number
    1628664-2010-00432
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 9, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: CAUSE OF DISCREPANT RESULTS IS UNKNOWN. AN ABBOTT SUPPORT PERSON CHECKED THE INSTRUMENT AND RAN PRECISION WHICH PASSED. NO FURTHER INFORMATION WAS DOCUMENTED. TRACKING AND TRENDING SHOWED NO SYSTEMIC ISSUE WITH THE C8000. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE TROUBLESHOOTING ASSISTANCE FOR ERRATIC RESULTS, POOR PRECISION FOR ICT RESULTS WITH MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS. BASED ON THE INFORMATION PROVIDED NO DEFICIENCY CAN BE IDENTIFIED.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT C8000 ANALYZER HAS GENERATED DISCREPANT SODIUM (NA) POTASSIUM (K) AND CHLORIDE (CL) RESULTS ON A PATIENT SAMPLE. NA: 103.4 (INITIAL RESULT), RE RUN: 107.0 MMOL/L ((B)(6) 2010), 136.5 MMOL/L ((B)(6) 2010). K: 3.41 (INITIAL RESULT), RE RUN: 3.42 MMOL/L ((B)(6) 2010), 4.21 MMOL/L ((B)(6) 2010). CL: 93.9 (INITIAL RESULT), RE RUN: 94.7 MMOL/L ((B)(6) 2010), 101.3 MMOL/L ((B)(6) 2010). THE ACCOUNT STATED THE RESULTS ARE DISCREPANT WITHIN 2 DAYS OF TESTING FOR THE SAME PATIENT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 AEROSET ICT MODULE LIST 9D28-03 LOT 00308032