BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 10440613 · Received August 23, 2020

    Report

    Report Number
    3016438761-2020-00187
    Event Type
    Malfunction
    Date Received
    August 23, 2020
    Date of Event
    August 4, 2020
    Report Date
    December 7, 2020
    Manufacturer
    ABBOTT LABORATORIES (IRVING IA/CC)
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND REPLACED THE ICT WARMING RING (ROHS, PART NUMBER 2-201662-01, ICT REFERENCE CUP, (ROHS), PART NUMBER 2-201664-02, TUBING, ICT ASPIRATION (ROHS), PART NUMBER 7-202639-01, TBG, ICT VALVE NO TO WASTE (ROHS), PART NUMBER 7-203000-01 WHICH RESOLVED THE ISSUE. A REVIEW OF INSTRUMENT SERVICE HISTORY ON SERIAL NUMBER (B)(6), REVEALED NO FURTHER OCCURRENCES OF DISCREPANT RESULTS AFTER THE PART REPLACED NOR DID IT IDENTIFY ANY SERVICE OR COMPLAINT ISSUES THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF THE CLINICAL CHEMISTRY SYSTEMS TRACKING, AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE DISCREPANT RESULTS DESCRIBED IN THIS COMPLAINT. A REVIEW OF HISTORICAL DATA FOR THE ICT WARMING RING, ICT REFERENCE CUP, (ROHS), TUBING, ICT ASPIRATION (ROHS), TBG, ICT VALVE NO TO WASTE (ROHS) DID NOT IDENTIFY ANY TRENDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE LIKELY CAUSE PARTS OR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE BELLOW SET AND ARCHITECT C16000 PROCESSING MODULE, SERIAL NUMBER (B)(6) WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER = SID= (B)(6). 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

    CUSTOMER OBSERVED FALSELY ELEVATED SODIUM RESULTS ON C16000 PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2020. SID (B)(6) INITIAL SODIUM RESULT=164.9 MMOL/L/ REPEATED=144 MMOL/L. SID (B)(6) INITIAL SODIUM RESULT=163.5 MMOL/L/ REPEATED=142 MMOL/L. SID (B)(6) INITIAL SODIUM RESULT=166.7 MMOL/L/ REPEATED=139 MMOL/L. SID (B)(6) INITIAL SODIUM RESULT=168.1 MMOL/L/ REPEATED=142 MMOL/L. SID (B)(6) INITIAL SODIUM RESULT=165.3 MMOL/L/ REPEATED=142 MMOL/L. SID (B)(6) INITIAL SODIUM RESULT=165.6 MMOL/L/ REPEATED=142 MMOL/L. SID (B)(6) INITIAL SODIUM RESULT=164.6 MMOL/L/ REPEATED=141 MMOL/L. SID (B)(6) INITIAL SODIUM RESULT=163.4 MMOL/L/ REPEATED=139 MMOL/L. SID (B)(6) INITIAL SODIUM RESULT=163.0 MMOL/L/ REPEATED=139 MMOL/L. REFERENCE NORMAL RANGE FOR SODIUM=136 TO 145 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904961 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT LABORATORIES (IRVING IA/CC) 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 CONC ICT DILUENT| CONC ICT DILUENT, 02P32-11,| LIST # 02P32-11