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	03/28/2025
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 abbott technical support specialist (tss) observed charring on the ac/dc controller board on an architect c4000 analyzer.The tss was onsite due to the customer reporting instrument error message, 5373 ¿ ac/dc controller board failure, and noticed the charring on the board.It was noted that the cause of the charring was liquid falling on the ac/dc controller board.The board was replaced, and the instrument is working as expected.There was no impact to patient management, user safety, or facility damage reported.
Additional Manufacturer Narrative
An abbott technical support specialist (tss) was dispatched due to instrument error messages on an architect c4000 processing module, serial number (b)(6).During the troubleshooting, the tss discovered charring/signs of short circuit on the ac/dc controller board.No fire was observed, and no injury occurred.The tss replaced the bd., ac/dc controller (rohs), part number 7-93183-04, which resolved the issue.The analyzer was returned to normal operation.The 2025 ul certification memo 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 charring/burning, observed was limited to the bd., ac dc controller (rohs), part number 7-93183-04; the charring/burning did not spread to other parts of the module.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 the information provided and abbott diagnostics' complaint investigation, no systemic issue or product deficiency was identified.
Event or Problem Description
The abbott technical support specialist (tss) observed charring on the ac/dc controller board on an architect c4000 analyzer.The tss was onsite due to the customer reporting instrument error message, 5373 ¿ ac/dc controller board failure, and noticed the charring on the board.It was noted that the cause of the charring was liquid falling on the ac/dc controller board.The board was replaced, and the instrument is working as expected.There was no impact to patient management, user safety, or facility damage 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: 21843090
• Report Number: 3016438761-2025-00226
• Device Sequence Number: 15419146
• Product Code: JJE
• UDI-Device Identifier: 00380740003746
• UDI-Public: (01)00380740003746
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 04/30/2025

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: 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: 03/28/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2015
• 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