BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 12462312 · Received September 13, 2021

    Report

    Report Number
    3016438761-2021-00324
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    August 26, 2021
    Report Date
    September 28, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ANALYZER, PERFORMED TROUBLESHOOTING, AND DETERMINED THE Y FTG (ROHS) WAS DETERMINED TO BE THE CAUSE OF THE ISSUE AND THE PART WAS CLEANED. CLEANING OF THE Y FTG (ROHS) RESOLVED THE ISSUE. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR (B)(4). , AS DESCRIBED IN THIS COMPLAINT. 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 DID NOT REVEAL ANY TRENDS FOR THE ARCHITECT C4000 SYSTEM OR THE Y FTG (ROHS) INSTRUMENT PART. ADDITIONALLY, LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. 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 C4000 SYSTEM SERVICE AND SUPPORT MANUAL PROVIDES INSTRUCTION FOR THE REMOVAL AND REPLACEMENT OF THE Y FTG (ROHS). THE CALCULATED ERRATIC RATES FOR THE ARCHITECT C4000, C8000, AND THE C16000 SYSTEMS WERE ALL BELOW THE UPPER CONTROL LIMIT. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    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 OBSERVED FALSELY DEPRESSED SODIUM RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL SODIUM RESULT 119 MMOL/L, REPEATS 119 MMOL/L AND 147 MMOL/L (NORMAL REFERENCE RANGE 133 TO 147 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357844 ARCHITECT C4000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 2P24-40 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1