BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 11921356 · Received June 2, 2021

    Report

    Report Number
    3016438761-2021-00201
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    April 27, 2021
    Report Date
    July 6, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INVESTIGATION OF THE ARCHITECT C16000 PROCESSING MODULE, SN (B)(6), SERVICE DETERMINED THE TBG, MANIFOLD TO ACD NOZZLE A (ROHS) (7-203019-01) WAS THE CAUSE OF THE CUSTOMER ISSUE, DUE TO BLOCKAGE. SERVICE REMOVED THE BLOCKAGE AND THE TBG, MANIFOLD TO ACD NOZZLE A (ROHS) (7-203019-01) WAS REPLACED, WHICH RESOLVED THE ISSUE. A REVIEW OF THE (B)(6) SERVICE HISTORY REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS WERE REPORTED FOR THIS PROCESSING MODULE. 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 TRENDING FOR THE TBG, MANIFOLD TO ACD NOZZLE A (ROHS) (7-203019-01 DID NOT IDENTIFY ANY TRENDS. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR THE ARCHITECT C16000 PROCESSING MODULE. MANUFACTURING DOCUMENTATION WAS REVIEWED AND NO ISSUES WERE IDENTIFIED. THE CALCULATED ERRATIC RATES FOR THE ARCHITECT C4000, C8000, AND THE C16000 SYSTEMS WERE ALL BELOW THE UPPER CONTROL LIMIT. LABELLING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CUSTOMER ISSUE, WHICH INCLUDES OPERATIONAL PRECAUTIONS LIMITATIONS AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM, TROUBLESHOOTING OF ELEVATED CONCENTRATION AND ERRATIC SAMPLE RESULTS, AND REMOVAL AND REPLACEMENT PROCEDURES FOR THE TBG, MANIFOLD TO ACD NOZZLE A (ROHS) (7-203019-01). BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE TBG, MANIFOLD TO ACD NOZZLE A (ROHS) (7-203019-01) OR THE ARC C16K PRC MOD SERIAL NUMBER (B)(6).

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3005094123-2021-00084 UNDER A DIFFERENT SUSPECT DEVICE. AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM RESULTS WERE GENERATED FOR A SAMPLE ON THE ARCHITECT C16000 ANALYZER. THE CUSTOMER STATED SAMPLE NO. C16951 GENERATED AN INITIAL RESULT OF 3.38 MMOL/L, WITH REPEAT RESULTS OF 0.60 MMOL/L AND 0.60 MMOL/L. THE CUSTOMER THEN REPORTED THE SAMPLE GENERATED A RESULT OF 3.68 MMOL/L AND THEN REPEATED WITHIN NORMAL RANGE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815921 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 CC MAGNESIUM (1000T), 03P68-24, 25901UD00| CC MAGNESIUM (1000T), 03P68-24, 25901UD00| CC MAGNESIUM (1000T), 03P68-24, 25901UD00