BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 12443039 · Received September 8, 2021

    Report

    Report Number
    3016438761-2021-00321
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 19, 2021
    Report Date
    November 3, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED DUE TO THE CUSTOMER REPORTING A FALSELY ELEVATED SODIUM RESULT ON THE ARCHITECT C16000, SERIAL NUMBER (B)(6). THROUGH AN EXTENSIVE INVESTIGATION, THE FSR FOUND THE SAMPLE PROBE, LIST NUMBER 01G48-04, C16 RGT PR(L)ROHS, LIST NUMBER 09D48-03, ICT MODLE, LIST NUMBER 09D28-04, AND THE BELLOWS, BELLOWS ONLY (ROHS), PART NUMBER 2-89054-02, NEEDED TO BE REPLACED, AND THE CUVETTES NEEDED TO BE MANUALLY CLEANED, WHICH RESOLVED THE CUSTOMER¿S COMPLAINT. THERE HAVE BEEN NO FURTHER REPORTS OF DISCREPANT SODIUM RESULTS REPORTED BY THE CUSTOMER SINCE THE CURRENT COMPLAINT. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO TRENDS FOUND. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED SODIUM RESULT FOR ONE PATIENT ON AN ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 135-145 MMOL/L): SAMPLE ID (B)(6) INITIAL RESULT WAS 166, REPEAT WAS 137 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340203 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1