BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR

    MDR report key: 17775783 · Received September 19, 2023

    Report

    Report Number
    3016438761-2023-00504
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    August 28, 2023
    Report Date
    September 22, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740001544
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. SECTION A1 - 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 ELEVATED ARCHITECT STAT TROPONIN-I RESULTS ON THE ARCHITECT I1000SR, SERIAL NUMBER (B)(6). THROUGH AN EXTENSIVE INVESTIGATION, THE FSR FOUND THE MANIFOLD VALVE KIT (ROHS), PART NUMBER 7-77612-03, LEAKING, AND THE ASSY, TRIGGER_ PRE-TRIGGER HEATER, COMPLETE (ROHS), PART NUMBER 7-200599-02, WORN, AND REPLACED THEM, WHICH RESOLVED THE CUSTOMER¿S COMPLAINT. 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 ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR A 50-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL REFERENCE RANGE IS <0.026 NG/ML): SAMPLE ID: (B)(6). INITIAL RESULT, ON 28AUG, WAS 6.966, REPEAT WAS <0.006 NG/ML. THE PATIENT WAS REDRAWN ON 29AUG, AND THE RESULT GENERATED ON A DIFFERENT ANALYZER WAS <0.006 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR A 50-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL REFERENCE RANGE IS <0.026 NG/ML): SAMPLE ID (B)(6) INITIAL RESULT, ON 28AUG, WAS 6.966, REPEAT WAS <0.006 NG/ML. THE PATIENT WAS REDRAWN ON 29AUG, AND THE RESULT GENERATED ON A DIFFERENT ANALYZER WAS <0.006 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997315 ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740001544

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female ARC TROP RGT, 02K41-27, 37320UN23| ARC TROP RGT, 02K41-27, 37320UN23