BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 12374115 · Received August 26, 2021

    Report

    Report Number
    3016438761-2021-00311
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    July 28, 2021
    Report Date
    September 2, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD SERVICE INSPECTED THE ARCHITECT C8000 PROCESSING MODULE, SN (B)(6), AND DETERMINED THE VALVE,WASH SOL PUMPS AND DI FILL (ROHS) (2-89561-03), CUVETTE DRYING TIP (09D51-01) , MIXER (09D59-03), AND THE HOLDER, CUVETTE (ROHS)(7-93114-01) WERE THE CAUSES OF THE CUSTOMER ISSUE. THE VALVE,WASH SOL PUMPS AND DI FILL (ROHS) (2-89561-03), CUVETTE DRYING TIP (09D51-01) , AND MIXER (09D59-03) WERE REPLACED AND THE HOLDER, CUVETTE (ROHS) (7-93114-01) WAS CLEANED. PART REPLACEMENT AND CLEANING RESOLVED THE ISSUE. THE SERVICE HISTORY FOR THE ARCHITECT C803278 WAS REVIEWED AND REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS WERE REPORTED. THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE VALVE, WASH SOL PUMPS AND DI FILL, CUVETTE DRYING TIP , MIXER, AND THE HOLDER, CUVETTE DID NOT IDENTIFY ANY TRENDS FOR THESE PARTS. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT C8000 PROCESSING MODULE WAS CONDUCTED AND NO TRENDS WERE IDENTIFIED FOR DISCREPANT RESULTS FOR THE ARCHITECT C8000 AS DESCRIBED IN THIS COMPLAINT. THE RATE OF ERRATIC RESULTS FOR THE C8000 WAS NOTED TO BE BELOW THE UPPER CONTROL LIMIT. MANUFACTURING DOCUMENTATION WAS REVIEWED AND NO ISSUES WERE IDENTIFIED. ADDITIONALLY, LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CUSTOMER ISSUE. LABELING PROVIDES INFORMATION SUCH AS OPERATIONAL PRECAUTIONS AND LIMITATIONS, TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM, COMPONENT REPLACEMENT/TROUBLESHOOTING OF ELEVATED CONCENTRATION AND ERRATIC SAMPLE RESULTS, AS WELL AS INSTRUCTIONS FOR REMOVAL AND REPLACEMENT OF THE VALVE,WASH SOL PUMPS AND DI FILL (ROHS), AND CUVETTE HOLDER. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE VALVE, WASH SOL PUMPS AND DI FILL, MIXER, CUVETTE HOLDER OR THE ARCHITECT C8000 PROCESSING MODULE.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. NO ADDITIONAL INFORMATION WAS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT MAGNESIUM RESULTS WERE GENERATED ON THE ARCHITECT C8000 ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: [REFERENCE RANGE 1.6 TO 2.6 MG/DL]: (B)(6) 2021 SID (B)(6) INITIAL RESULT 8.2 MG/DL; REPEAT 2.0 MG/DL. (B)(6) 2021 SID (B)(6) INITIAL RESULT 8.1 MG/DL; REPEAT 1.9 MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270313 ARCHITECT C8000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 1G06-11 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1 CC MAGNESIUM(3750T), 03P68-32, 81717UN21| CC MAGNESIUM(3750T), 03P68-32, 81717UN21| CC MAGNESIUM(3750T), (B)(4)