BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR PROCESSING MODULE

    MDR report key: 23359738 · Received October 22, 2025

    Report

    Report Number
    3016438761-2025-00618
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 5, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740001537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SERVICE INSPECTED THE INSTRUMENT AND FOUND THE ARC SNSR LVL PRE WAS BROKEN AND ONLY DISPENSING AIR. THE ARC SNSR LVL PRE WAS REPLACED AND RESOLVED THE ISSUE. THE MODULE FUNCTION WAS VERIFIED WITH A CONTROL RUN. INSTRUMENT SERVICE HISTORY WAS REVIEWED AND FOUND NO SUBSEQUENT DISCREPANT PATIENT RESULT ISSUES OR ERROR CODES HAVE BEEN REPORTED SINCE THE CURRENT ISSUE WAS IDENTIFIED. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ARCHITECT I1000SR PROCESSING MODULE DID NOT IDENTIFY ANY SIMILAR ISSUES AS DESCRIBED IN THE COMPLAINT. ADDITIONALLY, A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ARC SNSR LVL PRE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES FOR THE PART ASSOCIATED WITH THIS COMPLAINT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT I1000SR, SN (B)(6), OR THE INSTRUMENT PART.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED MULTIPLE ERROR CODES (1005 UNABLE TO CALCULATE RESULT. RLU OUTSIDE LOWEST CAL, 1007 ERROR DURING ACTIVATED MEASUREMENT, 1011 ERROR DURING FOREGROUND MEASUREMENT) FOLLOWED BY A FALSE NEGATIVE HIV RESULT GENERATED ON AN ARCHITECT I1000SR ANALYZER FOR ONE PATIENT. SID V040527 INITIAL RESULT = NEGATIVE, REPEAT RESULT ON ANOTHER ARCHITECT = POSITIVE, NO ACTUAL RESULTS WERE PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED MULTIPLE ERROR CODES (1005 UNABLE TO CALCULATE RESULT. RLU OUTSIDE LOWEST CAL, 1007 ERROR DURING ACTIVATED MEASUREMENT, 1011 ERROR DURING FOREGROUND MEASUREMENT) FOLLOWED BY A FALSE NEGATIVE HIV RESULT GENERATED ON AN ARCHITECT I1000SR ANALYZER FOR ONE PATIENT. SID (B)(6), INITIAL RESULT = NEGATIVE, REPEAT RESULT ON ANOTHER ARCHITECT = POSITIVE, NO ACTUAL RESULTS WERE PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606777 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 HIV AG/AB RGT 100T, 04J27-27, 77571BE00.| ARC HIV AG/AB RGT 100T, 04J27-27, 77571BE00.