BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 16673129 · Received April 4, 2023

    Report

    Report Number
    3016438761-2023-00176
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 12, 2023
    Report Date
    April 18, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT, PERFORMED TROUBLESHOOTING PROCEDURES INCLUDING REBUILDING THE SAMPLE SYRINGE, REPLACING THE SAMPLE PROBE TUBING AND THE TBG, SMPL PMP TO PIPET JNT, NS (ROHS) AS IT WAS KINKED AND CAUGHT UNDER A PANEL. PART REPLACEMENT RESOLVED THE ISSUE. NO ADDITIONAL DISCREPANT RESULT TOTAL BILIRUBIN ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. THE TBG, SMPL PMP TO PIPET JNT, NS (ROHS) WAS DETERMINED TO BE THE CAUSE OF THE ISSUE. THE ARCHITECT C8000 ERRATIC RESULT RATES WERE WITHIN ACCEPTABLE LIMITS WITH NO TRENDS IDENTIFIED. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE UNDER REVIEW. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 0.2 TO 1.3 MG/DL): SID L913045389 INITIAL 0.6 MG/DL, REPEAT 9.9 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385910 ARCHITECT C8000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 1G06-11 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CC TOTAL BILI (3840T), 06L45-42, 62899UQ09| CC TOTAL BILI (3840T), 06L45-42, 62899UQ09