BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 11728398 · Received April 26, 2021

    Report

    Report Number
    3016438761-2021-00158
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    April 16, 2021
    Report Date
    June 17, 2021
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6. COMPONENT CODE: G03001. ABBOTT FIELD SERVICE (FS) INVESTIGATED THE ISSUE ON SITE. THE ANALYZER WAS INSPECTED, AND VARIOUS DIAGNOSTIC CHECKS OF THE SYSTEM AND CLEANING WERE PERFORMED. FS REPLACED THE CUVETTE WASHER NOZZLE. WHICH WAS DETERMINED, TO BE THE LIKELY CAUSE. THERE HAVE BEEN NO FURTHER REPORTS OF DISCREPANT RESULTS SINCE THE NOZZLE WAS REPLACED. A REVIEW OF THE ARCHITECT SN# (B)(6) SERVICE HISTORY WAS NOT ABLE TO IDENTIFY OR CONFIRM ANY ADDITIONAL LIKELY CAUSES. A REVIEW OF HISTORICAL DATA REVEALED, NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. A REVIEW OF THE CLINICAL CHEMISTRY SYSTEMS REVEALED, FOUND NO SYSTEMIC ISSUES OR TRENDS FOR THE ISSUE ASSOCIATED WITH THIS TICKET (ERRATIC/DISCREPANT RESULTS). MANUFACTURING DOCUMENTATION FOR THE LIKELY, CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELLING ADEQUATELY ADDRESSES SAMPLE RESULTS OBSERVED, PROBLEMS FOR ERRATIC/DISCREPANT RESULTS. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT C8000 ANALYZER.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICE BY A THIRD PARTY? NO. AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER SIDS: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT SODIUM AND POTASSIUM RESULTS GENERATED ON THE ARCHITECT C16000 ANALYZER ON TWO PATIENTS. RESULTS PROVIDED: (B)(6) 2021 SID (B)(6): SODIUM = 181 / 138, POTASSIUM = 6.60 / 4.14; (B)(6) 2021 SID (B)(6): SODIUM = 104 / 140. NORMAL RANGE: SODIUM: 136-145 MMOL/L, POTASSIUM: 3.5-5.1 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619195 ARCHITECT C8000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1