MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I1000SR PROCESSING MODULE (INTEGRATED); ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01L86-40
Medical Device Problem Codes	Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available information was included.Additional details are not available.
Event or Problem Description
The customer observed sparks and smoke coming from underneath the architect i1000sr when performing daily maintenance.The device was immediately disconnected from the power supply.It was observed that the cable feeding the i1000sr power supply to the ups was twisted and showed signs of burns.It was confirmed that the short circuit was generated due to damaged cable that goes from the i1000sr power supply to the ups.The cable was replaced, and the issue resolved.No impact to patient management or user safety was reported.
Event or Problem Description
The customer observed sparks and smoke coming from underneath the architect i1000sr when performing daily maintenance.The device was immediately disconnected from the power supply.It was observed that the cable feeding the i1000sr power supply to the ups was twisted and showed signs of burns.It was confirmed that the short circuit was generated due to damaged cable that goes from the i1000sr power supply to the ups.The cable was replaced, and the issue resolved.No impact to patient management or user safety was reported.
Additional Manufacturer Narrative
The complaint investigation for sparks and smoke coming from underneath the architect i1000sr processing module, serial number (b)(6), included a review of the instrument service history, a search for similar complaints, ticket trending review, and labeling review.Return testing was not completed as returns were not available.The instrument service history review for (b)(6) revealed no additional tickets associated with smoke.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of tracking and trending for the architect (b)(6) processing module did not identify an increase in complaint activity.A review of tracking and trending for the assy, pdu power cable (rohs) did not identify an increase in complaint activity.Review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect (b)(6) processing module for serial (b)(6) or the assy, pdu power cable (rohs) were identified.

• Brand Name: ARCHITECT I1000SR PROCESSING MODULE (INTEGRATED)
• 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: 21993149
• Report Number: 3016438761-2025-00274
• Device Sequence Number: 11840293
• Product Code: JJE
• UDI-Device Identifier: 00380740001544
• UDI-Public: (01)00380740001544
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 06/03/2025

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: 01L86-40
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• 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