BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 16751835 · Received April 17, 2023

    Report

    Report Number
    3016438761-2023-00211
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    April 5, 2023
    Report Date
    May 12, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT, ARCHITECT C16000, SERIAL NUMBER (B)(6). THE FIELD SERVICE REPRESENTATIVE (FSR) RESOLVED THE ISSUE BY REPLACING PARTS INCLUDING THE BELLOWS, BELLOWS ONLY (ROHS) (2-89054-02). NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. THE BELLOWS, BELLOWS ONLY (ROHS) (2-89054-02) WERE DETERMINED TO BE THE LIKELY CAUSES OF THE ISSUE. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR (B)(6).THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF TRACKING AND TRENDING OF THE ARCHITECT C16000 DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT C16000 PROCESSING MODULE, SERIAL NUMBER (B)(6), WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY INCREASED TOTAL BILIRUBIN RESULT GENERATED ON THE ARCHITECT C16000 ANALYZER FOR ONE PATIENT. THE CUSTOMER REPEATED THE SAMPLE WHICH GENERATED A LOWER RESULT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 130.5, REPEAT RESULT = 9.04 THE SAMPLE WAS CENTRIFUGED AGAIN AND REPEATED RESULT = 10.3 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318952 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CC TOTAL BILI (2750T), 06L45-22, (B)(6)| CC TOTAL BILI (2750T), 06L45-22, (B)(6)