BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 12954559 · Received December 7, 2021

    Report

    Report Number
    3016438761-2021-00509
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    November 17, 2021
    Report Date
    January 7, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION: NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    DURING SITE VISIT BY ABBOTT FIELD SERVICE (FSR), THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ANALYZER DETERMINED THE JOINT, TBG, REAGENT ARMS (ROHS) (2-89233-02) THE LIKELY CAUSES OF THE ISSUE. THE REPLACEMENT OF PARTS WHICH RESOLVED THE ISSUE. A REVIEW OF THE ANALYZER SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT A REVIEW OF THE ARCHITECT C8000 PROCESSING MODULE, SERIAL NUMBER (B)(6). A SERVICE HISTORY FOUND NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. A REVIEW OF TRACKING AND TRENDING OF THE ARCHITECT C8000 PROCESSING MODULE OR THE PARTS, DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM. THE OPERATIONS MANUAL ALSO ADDRESSES TROUBLESHOOTING OF DEPRESSED CONCENTRATION AND ERRATIC SAMPLE RESULTS. THE ARCHITECT C8000 SYSTEMS SERVICE AND SUPPORT MANUAL, PROVIDES REMOVAL AND REPLACEMENT PROCEDURES FOR THE JOINT, TBG, REAGENT ARMS (ROHS) (2-89233-02). A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT C8000 PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE JOINT, TBG, REAGENT ARMS (ROHS) (2-89233-02).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM RESULTS ON ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL SODIUM=(B)(6) MMOL/L /REPEATED ON SAME ANALYZER=(B)(6) MMOL/L /REPEATED ON OTHER ARCHITECT=(B)(6) MMOL/L. LABORATORY REFERENCE RANGE FOR SODIUM=136 TO 144 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850544 ARCHITECT C8000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 1G06-11 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CC ICT SAMPLE DILUENT, 0K318-05,| CC ICT SAMPLE DILUENT, 0K318-05,