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

Catalog Number	03M74-98
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2025
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 a burning smell emanating from the architect i2000sr analyzer.Upon inspection by abbott field service, burn marks were found on the antenna board of the sample handler for stat pipettors.No impact to user safety or patient management was reported.
Additional Manufacturer Narrative
The field service engineer (fse) upon inspection determined that the lls antenna sample handler was the likely cause.There was no further damage to the instrument.A review of the analyzer service history and logs identified no contributing factors to the current complaint.There have been no further occurrences since the part was replaced by the fse.The architect operations manual contains adequate information for troubleshooting the observed issue.Manufacturing documentation for the likely cause did not identify any issues associated with the complaint issue.A review of the immunoassay platforms tracking and trending data revealed no systemic issues or trends with regards to the current issue.Based on the investigation no systemic issue or deficiencies were identified.
Event or Problem Description
The customer reported a burning smell emanating from the architect i2000sr analyzer.Upon inspection by abbott field service, burn marks were found on the antenna board of the sample handler for stat pipettors.No impact to user safety or patient management was reported.

• Brand Name: ARCHITECT I2000SR PROCESSING MODULE, REFURBISHED
• 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: 23242884
• Report Number: 3016438761-2025-00587
• Device Sequence Number: 10236550
• Product Code: JJE
• UDI-Device Identifier: 00380740068851
• UDI-Public: (01)00380740068851
• 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): 10/16/2025

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: 03M74-98
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2005
• 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