MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I1000SR PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01L86-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: ARCHITECT I1000SR PROCESSING MODULE
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 24712252
• Report Number: 3016438761-2026-00173
• Device Sequence Number: 14884721
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 01L86-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC SEPTUM 200-PK, 04D18-03, 000933922; ARC SEPTUM 200-PK, 04D18-03, 000933922
• Patient Sex: Female