BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 16069737 · Received December 29, 2022

    Report

    Report Number
    3016438761-2022-00610
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    November 29, 2022
    Report Date
    January 17, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. PATIENT IDENTIFIER- PATIENT IDENTIFIER COMPLETE ENTRY = (B)(6). 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 FALSELY DECREASED TSH RESULTS ON THE ARCHITECT I2000SR, SERIAL NUMBER (B)(6). THROUGH AN EXTENSIVE INVESTIGATION, THE FSR FOUND A LEAKING WASH ZONE 2 VACUUM VESSEL AND REPLACED THE VACUUM VESSEL REBUILD KIT (ROHS), PART NUMBER 7-77712-03, WHICH RESOLVED THE CUSTOMER¿S COMPLAINT. THERE HAVE BEEN NO FURTHER REPORTS OF DISCREPANT RESULTS REPORTED BY THE CUSTOMER SINCE THE PART WAS REPLACED. 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 FALSELY DECREASED ARCHITECT TSH RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT WAS 1.71, REPEAT WAS 2.54 MIU/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354975 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC TSH RGT, 07K62-30, 39359UD00| ARC TSH RGT, 07K62-30, 39359UD00