BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 10742246 · Received October 27, 2020

    Report

    Report Number
    3016438761-2020-00265
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    September 29, 2020
    Report Date
    December 3, 2020
    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

    DURING THE SUBSEQUENT SITE VISIT BY THE FIELD SERVICE ENGINEER (FSE) THE ANALYZER (ARCHITECT SERIAL NUMBER (B)(6)) WAS INSPECTED, VARIOUS DIAGNOSTIC CHECKS OF THE SYSTEM AND A PART REPLACEMENT WAS PERFORMED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ANALYZER SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THERE HAVE BEEN NO FURTHER OCCURRENCES OF DISCREPANT RESULTS AFTER THE PART REPLACEMENT WAS PERFORMED BY THE FSE. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES SAMPLE RESULT OBSERVED PROBLEMS FOR ERRATIC/DISCREPANT RESULTS. A REVIEW OF THE CLINICAL CHEMISTRY SYSTEMS TRACKING AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE DISCREPANT RESULT DESCRIBED IN THIS COMPLAINT. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER SIDS: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED CHLORIDE RESULTS GENERATED ON THE ARCHITECT C16000 ANALYZER ON FIVE PATIENTS. RESULTS PROVIDED: (NO UNITS PROVIDED). SID: INITIAL REPEAT : (B)(6); 122; 106. (B)(6); 120; 105. (B)(6); 120; 107. (B)(6); 120; 105. (B)(6); 121; 108. CHLORIDE NORMAL RANGE: 98-107 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204718 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1