BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR

    MDR report key: 21337165 · Received February 7, 2025

    Report

    Report Number
    3016438761-2025-00086
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    December 30, 2024
    Report Date
    March 3, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740001544
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE REQUESTED SITE VISIT, THE FIELD SERVICE ENGINEER (FSE) REPLACED THE LEAKING VALVE, MANIFOLD KIT (PART NUMBER 7-77612-04) AND VALVE, BYPASS, 2 WAY (ROHS)_PART NUMBER 7-200607-02 WERE REPLACED, WHICH RESOLVED THE ISSUE. A REVIEW OF THE ARCHITECT I PROCESS MODULE, SERIAL NUMBER (B)(6) SERVICE HISTORY FOUND NO ADDITIONAL FALSE ELEVATED STAT TROPONIN RESULTS WERE REPORTED POST THE CURRENT EVENT WAS IDENTIFIED. A REVIEW OF TRENDING DATA ASSOCIATED WITH THE VALVE, MANIFOLD KIT (ROHS)_PART NUMBER 7-77612-04 AND VALVE, BYPASS, 2 WAY (ROHS)_PART NUMBER 7-200607-02 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM AND ADDRESSES TROUBLESHOOTING OF ELEVATED CONCENTRATION AND ERRATIC SAMPLE RESULTS. THE ARCHITECT I SYSTEM SERVICE MANUAL CONTAINED ADEQUATE INFORMATION FOR THE TROUBLESHOOTING, REMOVAL, REPLACEMENT AND VERIFICATION OF THE PARTS. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ARCHITECT I SERIAL NUMBER (B)(6), OR VALVE, MANIFOLD KIT AND BYPASS, 2 WAY MANIFOLD KIT.

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TROPONIN RESULTS FOR TWO PATIENTS. THE RESULT PROVIDED WERE: ON (B)(6) 2024 FIRST PATIENT: MALE: SID (B)(6) INITIAL=0.419 NG/ML /REPEATED=0.038 NG/ML. ON (B)(6) 2025 SECOND PATIENT: FEMALE: SID (B)(6) INITIAL=0.066 NG/ML /REPEATED=0.012 NG/ML LABORATORY REFERENCE RANGE FOR TROPONIN=0.05 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TROPONIN RESULTS FOR TWO PATIENTS. THE RESULT PROVIDED WERE: ON (B)(6) 2024 FIRST PATIENT: MALE: SID (B)(6) INITIAL=0.419 NG/ML /REPEATED=0.038 NG/ML ON (B)(6) 2025 SECOND PATIENT: FEMALE: SID (B)(6) INITIAL=0.066 NG/ML /REPEATED=0.012 NG/ML LABORATORY REFERENCE RANGE FOR TROPONIN=0.05 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881478 ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740001544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC TROP RGT, 02K41-27,| ARC TROP RGT, 02K41-27,