MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I2000SR; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03M74-01
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
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.This report is being filed on an international product, list number 03m74-01, that has a similar product distributed in the us, list number 03m74-02.
Event or Problem Description
The customer observed smoke coming from the abbottlink firewall adapter associated with an architect i2000sr analyzer.The customer reported that due to a leak from the liquid waste pump on the analyzer, the abbottlink firewall adapter was submerged, causing smoke and traces of melting on the adapter.There was no impact to patient management, user safety, or facility damage reported.No injuries occurred.
Event or Problem Description
The customer observed smoke coming from the abbottlink firewall adapter associated with an architect i2000sr analyzer.The customer reported that due to a leak from the liquid waste pump on the analyzer, the abbottlink firewall adapter was submerged, causing smoke and traces of melting on the adapter.There was no impact to patient management, user safety, or facility damage reported.No injuries occurred.
Additional Manufacturer Narrative
An abbott field service representative (fsr) was dispatched due to the customer reporting smoke emerging from the architect i2000sr, serial number (b)(6).During troubleshooting, the fsr found liquid from the waste pump leaked onto the firewall adapter causing a burning smell and smoke and the adapter showed signs of melting.The fsr replaced the arc x waste pmp i, list number 08c94-19, and alink firewall ¿ japan, list number 02p38-20, which resolved the issue.The analyzer was returned to normal operation.A review found the 2025 ul certification memo contains adequate information noting abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.The damaged components were limited to the arc x waste pmp i, list number 08c94-19, and the alink firewall ¿ japan, list number 02p38-20; the smoke did not spread to other parts of the instrument.A review of the instrument history revealed no contributing factors described in this complaint.A review of labeling and historical data was done, and both were adequate, with no increase in complaint activity.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency was identified.

• Brand Name: ARCHITECT I2000SR
• 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: 22808710
• Report Number: 3016438761-2025-00474
• Device Sequence Number: 9063564
• Product Code: JJE
• UDI-Device Identifier: 00380740023386
• UDI-Public: (01)00380740023386
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/27/2025

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: 03M74-01
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2016
• 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