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	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that there was an error message on the architect i1000sr instrument for a reagent carousel error.While performing troubleshooting and looking at the gaps in the rsm, liquid splashed on the customer¿s face.The customer was wearing gloves and glasses.The customer washed with water and did not require any treatment.No impact to patient management was reported.
Event or Problem Description
The customer stated that there was an error message on the architect i1000sr instrument for a reagent carousel error.While performing troubleshooting and looking at the gaps in the rsm, liquid splashed on the customer¿s face.The customer was wearing gloves and glasses.The customer washed with water and did not require any treatment.No impact to patient management was reported.
Additional Manufacturer Narrative
A customer was splashed on the face while troubleshooting a reagent carousel error generated on the architect i1000sr processing module serial number (b)(6).She was wearing gloves and glasses but no face shield at the time of the splash.The arc probe (08c94-42) was found to be bent and the cause of the splash.The arc probe was replaced and calibrated.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The instrument service history review revealed no additional complaints associated with the complaint.A review of tracking and trending did not identify an increase in complaint activity for both the architect i1000sr processing module and the arc probe with regards to the reported event.A review of the manufacturing documentation did not identify any issues as it relates to the arc probe and reported event.Labeling was reviewed and was found to address the reported event.Based on the available information, no systemic issue or deficiency was identified.

• 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: 23304502
• Report Number: 3016438761-2025-00604
• Device Sequence Number: 10027729
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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: 10/06/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2009
• 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
• Patient Sex: Unknown