BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 13315534 · Received January 21, 2022

    Report

    Report Number
    3016438761-2022-00034
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    December 28, 2021
    Report Date
    February 17, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER. 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 AND PERFORMED EXTENSIVE TROUBLESHOOTING, AND REPLACED MULTIPLE PARTS TO RESOLVE THE ISSUE. DETERMINED THE JOINT, TBG, REAGENT ARMS (ROHS) (2-89233-02) THE LIKELY CAUSES OF THE ISSUE. THE FOLLOWING PARTS 2-89055-02 BELLOWS SET ,INCL ROD & FITTING (ROHS), 09D41-03 1ML SYRINGE, 7-205228-02 NOZZLE C4 #1, #4, #5 (ROHS), 7-93136-02 MANIFOLD, DI TO CUV WASH (ROHS) REPLACEMENT WHICH RESOLVED THE ISSUE. A REVIEW OF THE ANALYZER SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. A REVIEW OF TRACKING AND TRENDING OF THE ARCHITECT C4000 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 OPERATIONS MANUAL ALSO ADDRESSES TROUBLESHOOTING OF DESCREPANT AND ERRATIC SAMPLE RESULTS. THE ARCHITECT C4000 SYSTEMS SERVICE AND SUPPORT MANUAL, PROVIDES REMOVAL AND REPLACEMENT PROCEDURES FOR THE ASSOCIATED PARTS. 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 C4000 PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE 2-89055-02 BELLOWS SET ,INCL ROD & FITTING (ROHS), 09D41-03 1ML SYRINGE, 7-205228-02 NOZZLE C4 #1, #4, #5 (ROHS), 7-93136-02 MANIFOLD, DI TO CUV WASH (ROHS).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM ON ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL=9.0 MG/DL /REPEATED ON ANOTHER ABBOTT ANALYZER=2.5 MG/DL LABORATORY NORMAL RANGE FOR MAGNESIUM=1.6 TO 2.6MG/DL; CRITICAL VALUES < 1 MG/DL AND > 4.5 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960840 ARCHITECT C4000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 2P24-40 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CC MAGNESIUM(1000T), 03P68-22, 47394UN21| CC MAGNESIUM(1000T), 03P68-22, 47394UN21