BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 12698804 · Received October 26, 2021

    Report

    Report Number
    3016438761-2021-00395
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    October 4, 2021
    Report Date
    November 17, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF ARCHITECT (B)(4) INSTRUMENT SERVICE HISTORY, IDENTIFIED NO CONTRIBUTING FACTORS TO THIS COMPLAINT. A REVIEW OF THE ARCHITECT C4000 PLATFORM FOUND ALL ERRATIC RESULTS WERE BELOW THE UPPER CONTROL LIMIT. A REVIEW OF HISTORICAL DATA FOR THE ARCHITECT C4000 WITH THIS COMPLAINT REVEALED NO TRENDS, SYSTEMIC ISSUES, OR NONCONFORMANCES. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR ARCHITECT C4000, SERIAL NUMBER (B)(4). SECTION A1 PATIENT IDENTIFIER SIDS: NO SID PROVIDED FOR THE 1ST PATIENT, 2ND PATIENT = (B)(6). ADDITIONAL PATIENT ADDED TO SECTION B5.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED SODIUM RESULT GENERATED ON AN ARCHITECT C4000 ANALYZER ON TWO PATIENTS. RESULTS PROVIDED: (B)(6) 2021 INITIAL = 100 / 142, ANOTHER ARCHITECT = 142 MMOL/L SID (B)(4) = 114 / 141 MMOL/L. NORMAL RANGE: 137-146 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY DECREASED SODIUM RESULT GENERATED ON AN ARCHITECT C4000 ANALYZER ON A PATIENT. RESULTS PROVIDED: INITIAL = 100 / 142, ANOTHER ARCHITECT = 142 MMOL/L. NORMAL RANGE: 137-146 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596103 ARCHITECT C4000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 2P24-40 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown AERO C8K ICT MOD, 09D28-03,| AERO C8K ICT MOD, 09D28-03,| CONC ICT DILUENT, 02P32-11,| CONC ICT DILUENT, 02P32-11,