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	07/31/2025
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 reported when she removed the waste tank of the architect i1000sr processing module to empty it and opened the spout, she states she felt a drop on her lip.She wiped it away, spit, and gargled with mouthwash.She stated it was not in her mouth and just on her lip; but did those precautions anyway.The customer reported she was wearing a laboratory coat, gloves, but no mask.No impact to patient management or further impact to user safety was reported.
Additional Manufacturer Narrative
The instrument service history revealed no contributing factors on or around the date of the issue.There have been no subsequent contacts from the customer regarding splashing occurrence since the reported incident.The current complaint is the sole complaint for splashing for the arc liquid waste tank.Data and information provided by the customer were reviewed and support the complaint issue.A review of complaint and trending data for the architect i1000sr processing module did not identify any similar issues related to the with regards to the current issue.Additionally review of complaint and trending data associated with the arc liquid waste tank 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 associated part.Labeling was reviewed and found to be adequate.Based on the investigation, the device met performance specification and performed as intended at the customer site, therefore there is no systemic issue or deficiency with the architect i1000sr processing module serial number (b)(6).
Event or Problem Description
The customer reported when she removed the waste tank of the architect i1000sr processing module to empty it and opened the spout, she states she felt a drop on her lip.She wiped it away, spit, and gargled with mouthwash.She stated it was not in her mouth and just on her lip; but did those precautions anyway.The customer reported she was wearing a laboratory coat, gloves, but no mask.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: 22848783
• Report Number: 3016438761-2025-00484
• Device Sequence Number: 8373299
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 07/31/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2012
• 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 LIQUID WASTE, 06L05-01, UNKNOWN; ARC LIQUID WASTE, 06L05-01, UNKNOWN
• Patient Sex: Female