BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR

    MDR report key: 17671907 · Received September 1, 2023

    Report

    Report Number
    3016438761-2023-00467
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    October 25, 2021
    Report Date
    September 1, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740116941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 1628664-2021-00013 UNDER THE SAME SUSPECT MEDICAL DEVICE BUT AN INCORRECT MANUFACTURER NAME, CITY AND STATE. COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ANALYZER REPLACED THE PROBE NEXT R (03R85-01), WHICH RESOLVED THE ISSUE. A REVIEW OF THE ARCHITECT I1000SR PROCESSING MODULE, SERIAL NUMBER (B)(6) SERVICE HISTORY FOUND NO CONTRIBUTING FACTORS ON OR AROUND THE DATE OF THE COMPLAINT. A REVIEW OF TRACKING AND TRENDING OF THE ARCHITECT I1SR PROCESSING MODULE OR THE PROBE NEXT R (03R85-01), DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. A REVIEW OF THE (B)(6) SERVICE HISTORY WAS PERFORMED AND NO ADDITIONAL ERRATIC RESULTS PRE- OR POST THE CURRENT COMPLAINT WERE IDENTIFIED. THE ARCHITECT SYSTEM OPERATIONS MANUAL ADDRESSES OPERATIONAL PRECAUTIONS AND LIMITATIONS AND TROUBLESHOOTING OF THE FLUIDICS SUBSYSTEM. THE OPERATIONS MANUAL ALSO ADDRESSES TROUBLESHOOTING OF ELEVATED CONCENTRATION AND ERRATIC SAMPLE RESULTS. 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 I1000SR PROCESSING MODULE, SERIAL NUMBER (B)(6) , OR THE PROBE NEXT R (03R85-01).

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS ON TWO PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL=128.49 NG/L /REPEATED=15.854 NG/L /REPEATED ON ANOTHER ANALYZER=11.055 NG/L. SID = (B)(6) INITIAL=561.252 NG/L /REPEATED=0.000 NG/L /REPEATED ON ANOTHER ANALYZER=0.00 NG/L. LABORATORY NORMAL REFERENCE RANGE = 55 - 74 NG/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249861 ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740116941

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown