BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR

    MDR report key: 14016583 · Received April 5, 2022

    Report

    Report Number
    3016438761-2022-00140
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    March 14, 2022
    Report Date
    May 6, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740001537
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED DUE TO THE CUSTOMER REPORTING A FALSELY DECREASED TSH RESULT ON AN ARCHITECT I1000SR, SERIAL NUMBER (B)(6). THROUGH AN EXTENSIVE INVESTIGATION, THE FSR FOUND THAT THE TRIGGER_PRE-TRIGGER HEATER WAS LEAKING. THE FSR PERFORMED MULTIPLE TROUBLESHOOTING SERVICES INCLUDING THE REPLACEMENT OF THE ASSY, TRIGGER_PRE-TRIGGER HEATER, COMPLETE (ROHS), PART NUMBER 7-200599-02, WHICH RESOLVED THE ISSUE. NO SUBSEQUENT ISSUES HAVE BEEN REPORTED. A REVIEW OF THE INSTRUMENT HISTORY REVEALED NO CONTRIBUTING FACTORS DESCRIBED IN THIS COMPLAINT. A REVIEW OF LABELING AND HISTORICAL DATA WAS DONE, AND BOTH WERE ADEQUATE, WITH NO TRENDS FOUND. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DECREASED ARCHITECT TSH RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 0.35-4.94 UIU/ML):SAMPLE ID (B)(6) INITIAL RESULT WAS 0.0706 UIU/ML. THE SAMPLE REPEATED AS 6.15 UIU/ML, WHICH BASED ON THE PATIENT¿S HISTORY, WAS DETERMINED TO BE THE CORRECT RESULT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842189 ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 1L86-01 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC TSH RGT, 07K62-25, 36202UD00| ARC TSH RGT, 07K62-25, 36202UD00