MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C4000 PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	02P24-01
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The field service representative (fsr) observed smoke/fire on the cnn board of the architect c4000 processing module during an onsite visit.The fsr identified that cnn board, cnn 31 cable & hcw pump (with smell of burnt parts) were burned.There was no damage to the customer facility.No impact to patient management or user safety was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the architect c4000 serial number (b)(6).When troubleshooting the issue of visible smoke and burning odor, the field service representative discovered evidence of burning/charring on the bd, cnn, c4 (rohs).The bd, cnn, c4 (rohs)_ and a blown pm fuse, 1a (rohs).Both the bd, cnn, c4 (rohs) and pm fuse, 1a (rohs) were replaced and deemed the cause for the issue.The instrument service history for the architect c4000, serial #(b)(6).Verifies no subsequent issues have been reported related to charred/burned parts after service intervention.A review of tracking and trending did not identify any trends regarding the event.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was found to be adequate for the complaint issue.Based on our investigation, no systemic issue or deficiency was identified.
Event or Problem Description
The field service representative (fsr) observed smoke/fire on the cnn board of the architect c4000 processing module during an onsite visit.The fsr identified that cnn board, cnn 31 cable & hcw pump (with smell of burnt parts) were burned.There was no damage to the customer facility.No impact to patient management or user safety was reported.

• Brand Name: ARCHITECT C4000 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: 24964759
• Report Number: 3016438761-2026-00232
• Device Sequence Number: 10496061
• Product Code: JJE
• UDI-Device Identifier: 00380740003746
• UDI-Public: (01)00380740003746
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 02P24-01
• 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: 04/05/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2017
• 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