BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I1000SR PROCESSING MODULE

    MDR report key: 24712252 · Received March 30, 2026

    Report

    Report Number
    3016438761-2026-00173
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 21, 2026
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740001537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS D3 EMAIL AND G1 MFG SITE EMAIL WERE UPDATED. WHEN REMOVING AN ARCHITECT SEPTUM OFF A PROBE CONDITIONING SOLUTION BOTTLE, LIQUID FROM THE SURFACE OF THE PROBE CONDITIONING SOLUTION BOTTLE SURFACE SPLASHED ONTO THE TESTER¿S FACE. THE SPLASH ONTO THE CUSTOMER¿S FACE OCCURRED WHILE THEY WERE NOT WEARING ALL PERSONAL PROTECTIVE EQUIPMENT (NO EYE PROTECTION WAS WORN, ONLY GLOVES WERE WORN). A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ARCHITECT SEPTUM LOT NUMBER 3120740. THE TRACKING AND TRENDING REVIEW FOR THE ARCHITECT SEPTUM DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION THE ARCHICTECT I1000SR, SERIAL NUMBER (B)(6) , AND ARCHITECT SEPTUM LOT 3120740 IS PERFORMING AS INTENDED. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHICTECT I1000SR AND/OR ARCHITECT SEPTUM WAS IDENTIFIED.

    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 ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED WHILE TRYING TO REMOVE THE SEPTUMS ON THE ARCHITECT I1000SR PROCESSING MODULE, LIQUID FROM THE SURFACE OF THE PROBE CONDITIONING SOLUTION BOTTLE SURFACE SPLASHED ON THEIR FACE. THE CUSTOMER IMMEDIATELY WASHED HER FACE IMMEDIATELY AND NO RASH OR SKIN IRRITATION WAS OBSERVED. THE CUSTOMER REPORTED ONLY GLOVES WERE BEING WORN AT THE TIME, NO MASK. NO MEDICAL INTERVENTION WAS REQUIRED. NO IMPACT TO PATIENT MANAGEMENT OR FURTHER IMPACT TO USER SAFETY WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED WHILE TRYING TO REMOVE THE SEPTUMS ON THE ARCHITECT I1000SR PROCESSING MODULE, LIQUID FROM THE SURFACE OF THE PROBE CONDITIONING SOLUTION BOTTLE SURFACE SPLASHED ON THEIR FACE. THE CUSTOMER IMMEDIATELY WASHED HER FACE IMMEDIATELY AND NO RASH OR SKIN IRRITATION WAS OBSERVED. THE CUSTOMER REPORTED ONLY GLOVES WERE BEING WORN AT THE TIME, NO MASK. NO MEDICAL INTERVENTION WAS REQUIRED. NO IMPACT TO PATIENT MANAGEMENT OR FURTHER IMPACT TO USER SAFETY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330625 ARCHITECT I1000SR PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740001537

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female ARC SEPTUM 200-PK, 04D18-03, 000933922| ARC SEPTUM 200-PK, 04D18-03, 000933922