BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR PROCESSING MODULE

    MDR report key: 22017896 · Received May 14, 2025

    Report

    Report Number
    3016438761-2025-00287
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 19, 2025
    Report Date
    July 17, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740001537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1: PATIENT IDENTIFIER: SAMPLE IDS: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT, PERFORMED EXTENSIVE TROUBLESHOOTING, AND DETERMINED THAT THE WASHZONE TEMPERATURE TUBING/SENSOR WAS THE LIKELY CAUSE OF THE ISSUE. THE FSR REPLACED THE PART, AND THE ISSUE WAS RESOLVED. AN INSTRUMENT SERVICE HISTORY REVIEW FOR THE ARCHITECT I1000SR, SERIAL NUMBER (B)(6), REVEALED NO ADDITIONAL SERVICE TICKETS RELATED TO FALSE POSITIVE TOTAL B-HCG RESULTS. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ARCHITECT I1000SR PROCESSING MODULE DID NOT IDENTIFY ANY SIMILAR ISSUES AS DESCRIBED IN THIS COMPLAINT. ADDITIONALLY, A REVIEW OF COMPLAINT AND TRENDING DATA ASSOCIATED WITH THE WASHZONE TEMPERATURE TUBING/SENSOR DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES WERE IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT I1000SR PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE WASHZONE TEMPERATURE TUBING/SENSOR WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TOTAL HCG RESULT GENERATED BY THE ARCHITECT I1000SR PROCESSING MODULE FOR THREE PATIENTS. THE SAMPLES WERE REPEATED, AND NEGATIVE RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED (= 5.00 MIU/ML IS NEGATIVE, >5.00 TO <25.00 MIU/ML IS GRAYZONE, = 25.00 MIU/ML IS POSITIVE): SID: (B)(6): ON (B)(6) 2025 INITIAL RESULT = 31.32 MIU/ML (POSITIVE). ON (B)(6) 2023 REPEAT RESULT = < 1.20 MIU/ML (NEGATIVE). SID: (B)(6): ON (B)(6) 2025 INITIAL RESULT = 2.99 MIU/ML (NEGATIVE). ON (B)(6) 2025 REPEAT RESULTS = 30.03 MIU/ML (POSITIVE), 7.69 MIU/ML (GRAYZONE), < 1.20 MIU/ML (NEGATIVE). SID: (B)(6): ON (B)(6) 2025 INITIAL RESULT = 47.48 MIU/ML (POSITIVE). ON (B)(6) 2025 REPEAT RESULTS = 19.05 MIU/ML (POSITIVE), < 1.20 MIU/ML (NEGATIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT TOTAL -HCG RESULT GENERATED BY THE ARCHITECT I1000SR PROCESSING MODULE FOR THREE PATIENTS. THE SAMPLES WERE REPEATED, AND NEGATIVE RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED (= 5.00 MIU/ML IS NEGATIVE, >5.00 TO <25.00 MIU/ML IS GRAYZONE, = 25.00 MIU/ML IS POSITIVE): SID (B)(6). (B)(6) 2025 INITIAL RESULT = 31.32 MIU/ML (POSITIVE) (B)(6) 2023 REPEAT RESULT = < 1.20 MIU/ML (NEGATIVE) SID (B)(6): (B)(6) 2025 INITIAL RESULT = 2.99 MIU/ML (NEGATIVE) (B)(6) 2025 REPEAT RESULTS = 30.03 MIU/ML (POSITIVE), 7.69 MIU/ML (GRAYZONE), < 1.20 MIU/ML (NEGATIVE) SID (B)(6): (B)(6) 2025 INITIAL RESULT = 47.48 MIU/ML (POSITIVE) (B)(6) 2025 REPEAT RESULTS = 19.05 MIU/ML (POSITIVE), < 1.20 MIU/ML (NEGATIVE) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630532 ARCHITECT I1000SR PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC BHCG RGT 100T, 06C21-26, UNKNOWN| ARC BHCG RGT 100T, 06C21-26, UNKNOWN