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	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2025
Type of Reportable Event	Malfunction
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, that is 510k exempt.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed visible smoke from a cable on the architect i1000sr instrument and instrument error message ¿5503 step loss detected on (trigger pump), actual (expected)¿.There was no reported impact to user safety.
Additional Manufacturer Narrative
A complaint investigation was conducted for the architect i1000sr serial number (b)(6).The field service representative observed the 100ul trigger pump (rohs) was loose and leaking onto the cable, pt_t pumps and sensors, w301 causing the cable to char/burn emitting smoke.The cable, pt_t pumps and sensors, w301 was replaced and the 100ul trigger pump (rohs) tightened to resolve the issue.Both parts were deemed the cause of the issue.The instrument service history for the architect i1000sr, serial number (b)(6) verifies no subsequent issues have been reported related to the module generating error code 5503 step loss detected on (trigger pump), actual (expected) or charred/burned parts.The 2025 ul certification indicates that 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 charred/burned part observed was limited to the cable, pt_t pumps and sensors, w301 due to the 100ul trigger pump (rohs) leaking, the charring/burning did not spread to other parts of the module.A review of tracking and trending did not identify any trends with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on our investigation, no systemic issue or deficiency was identified for the architect i1000sr, serial number (b)(6), the 100ul trigger pump (rohs), or the cable, pt_t pumps and sensors, w301.
Event or Problem Description
The customer observed visible smoke from a cable on the architect i1000sr instrument and instrument error message ¿5503 step loss detected on (trigger pump), actual (expected)¿.There was no reported impact to user safety.

• 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: 23837762
• Report Number: 3016438761-2025-00737
• Device Sequence Number: 18463611
• Product Code: JJE
• UDI-Device Identifier: 00380740001537
• UDI-Public: (01)00380740001537
• Combination Product (Y/N): N
• Initial Reporter Country: BG
• 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): 01/12/2026

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: 11/30/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2014
• 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