BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 10508384 · Received September 9, 2020

    Report

    Report Number
    3016438761-2020-00205
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Date of Event
    August 17, 2020
    Report Date
    September 9, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    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 · 1

    NO FURTHER PATIENT INFORMATION IS AVAILABLE. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND OBSERVED BUBBLES IN THE CUVETTE WASH PUMP BELLOWS AND THE INTERNAL PROBE WASH PUMP A BELLOWS. THE FSR REPLACED THE BELLOWS AND RESOLVED THE ISSUE. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. THE BELLOWS, BELLOWS ONLY (ROHS), PART NUMBER: 2-89054-02, WAS DETERMINED TO BE THE CAUSE FOR THE ISSUE. A REVIEW OF THE SERVICE HISTORY FOR THE ANALYZER IDENTIFIED NO CONTRIBUTING FACTORS AND NO ADDITIONAL TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC RESULTS HAVE BEEN REPORTED. A REVIEW OF MANUFACTURING DOCUMENTATION AND TRENDING DATA FOR THE BELLOWS IDENTIFIED NO ISSUES OR TRENDS. A REVIEW OF TRACKING AND TRENDING DATA IN THE PRODUCT MONITORING REVIEW FOR CLINICAL CHEMISTRY SYSTEMS REVEALED NO SYSTEMIC ISSUES OR TRENDS RELATED TO THE RESULT ISSUE DESCRIBED IN THIS COMPLAINT. THE ERRATIC RESULT RATES WERE REVIEWED AND ARE WITHIN ACCEPTABLE LIMITS WITH NO TRENDS IDENTIFIED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C16000 ANALYZER WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSELY ELEVATED ARCHITECT TOTAL BILIRUBIN RESULTS WHILE USING THE ARCHITECT C16000 ANALYZER. SAMPLE ID: (B)(6) GENERATED 260 AND 9 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975142 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT LABORATORIES (IRVING IA/CC) 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1