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	Red Eye(s) (2038)
Date of Event	07/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint investigation for a splashed in the eye with the architect concentrated wash buffer used on the architect i1000sr processing module included a review of data and information provided by the customer, a ticket trending review, a device history record review, and a labeling review.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A review of complaint and trending data for the architect concentrated wash buffer, list number 06c54, did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 70383fz00.A review of the device history record did not identify any non-conformances or deviations with lot 70383fz00 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.The safety data sheet for architect concentrated wash buffer, exposure control/personal protection section, outlines the requirements for personal protective equipment to be worn on use of this product: ¿wear safety glasses or other protective eyewear.If splash potential exists, wear full face shield or goggles.¿ based on the investigation, no systemic issue or deficiency was identified.The architect concentrated wash buffer (lot number 70383fz00) and the architect i1000sr processing module, serial number (b)(6), are performing as expected.
Event or Problem Description
The customer reported being splashed in the right eye with the wash buffer while preparing the wash buffer solution for the architect i1000sr processing module.She rinsed her eyes with water for one minute.Her eyes appeared red following the incident.The customer sought medical treatment and was prescribed tobradex eye drops.No further redness was observed after treatment.It was noted that the customer was wearing gloves but was not wearing protective goggles at the time of the incident.No further impact to patient management was reported.
Additional Manufacturer Narrative
This report is being filed on an international product, list number 01l86-01 that has the same product distributed in the us, list number 01l86-01, with 510k/pma/bla of exempt.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported being splashed in the right eye with the wash buffer while preparing the wash buffer solution for the architect i1000sr processing module.She rinsed her eyes with water for one minute.Her eyes appeared red following the incident.The customer sought medical treatment and was prescribed tobradex eye drops.No further redness was observed after treatment.It was noted that the customer was wearing gloves but was not wearing protective goggles at the time of the incident.No further impact to patient management 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: 22631717
• Report Number: 3016438761-2025-00432
• Device Sequence Number: 9251762
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 08/18/2025

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?: No
• 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: 07/20/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2012
• 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 CONC WSH BFR, 06C54-58, 70383FZ00.; ARC CONC WSH BFR, 06C54-58, 70383FZ00.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female