BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 9580806 · Received January 13, 2020

    Report

    Report Number
    1628664-2020-00017
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 31, 2019
    Report Date
    January 27, 2020
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5: TWO ADDITIONAL PATIENTS ADDED DURING THE SUBSEQUENT SITE VISIT BY THE FIELD SERVICE ENGINEER (FSE) THE ANALYZER WAS INSPECTED, AND A PART REPLACEMENT (HIGH CONCENTRATED WASTE TUBING) WAS PERFORMED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF THE ANALYZER SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. THERE HAVE BEEN NO FURTHER OCCURRENCES OF DISCREPANT RESULTS AFTER THE SERVICE ACTIVITY WAS PERFORMED BY THE FSE. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES SAMPLE RESULT OBSERVED PROBLEMS AND TROUBLESHOOTING FOR ERRATIC/DISCREPANT RESULTS. A REVIEW OF THE CLINICAL CHEMISTRY SYSTEMS TRACKING AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE DISCREPANT RESULT DESCRIBED IN THIS COMPLAINT. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED SODIUM (NA) AND CO2 RESULTS GENERATED ON THE ARCHITECT C8000 ON TWO ADDITIONAL PATIENTS. SID 1100080281: NA = 163 / 141 MMOL/L; SID (B)(6) : CO2 = 46 MMOL/L, ANOTHER ARCHITECT = 25 MMOL/L. REFERENCE RANGES: NA = (136-145 MMOL/L); CO2 = (22-29 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED SODIUM (NA) AND CHLORIDE (CL) RESULTS GENERATED ON THE ARCHITECT C8000 ON ONE PATIENT. RESULTS PROVIDED: NA = 185 / 140 MMOL/L / ANOTHER ARCHITECT = 142 MMOL/L; CL = 143 / 107 MMOL/L / ANOTHER ARCHITECT = 111 MMOL/L. REFERENCE RANGES: NA = (136-145 MMOL/L); CL = (98-107 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43357 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 1G06-11 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1