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	07/28/2025
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 field service representative was swapping out the old ups for the new ups and observed the port used to power the architect c4000 processing module showed signs of melting.The power spike that caused the damage appeared to have passed through the analyzer and it was noted damage was done to the sm acdc board, the mech led board, and the led3 cable that links the two.No impact to patient management or impact to user safety was reported.
Event or Problem Description
The field service representative was swapping out the old ups for the new ups and observed the port used to power the architect c4000 processing module showed signs of melting.The power spike that caused the damage appeared to have passed through the analyzer and it was noted damage was done to the sm acdc board, the mech led board, and the led3 cable that links the two.No impact to patient management or impact to user safety was reported.
Additional Manufacturer Narrative
The field service representative (fsr) replaced the cable, led3 to sm acdc (rohs), the sm ac/dc controller bd, c4 (rohs) (rohs) and the bd., mech led,m 16(rohs) on the architect c4000 processing module, serial number (b)(6) and the instrument returned to normal function after they were replaced.The instrument service history for the architect c4000 processing module, serial number (b)(6) verifies no subsequent issues have been reported.Data and information provided by the customer was reviewed and support the complaint issue.A review of complaint and trending data for the architect c4000 processing module did not identify any similar issues related to the with regards to the current issue.Additionally review of complaint and trending data associated with the cable, led3 to sm acdc (rohs), the sm ac/dc controller bd, c4 (rohs) (rohs) and the bd., mech led,m 16(rohs) did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances for the parts and complaint issue.Labeling was reviewed and found to be adequate.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 observed melted cable connector observed did not spread to other parts of the module.Based on the available information, no systemic issue or deficiency of the architect c4000 processing module for serial number (b)(6) was identified.

• 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: 22736959
• Report Number: 3016438761-2025-00459
• Device Sequence Number: 7218442
• Product Code: JJE
• UDI-Device Identifier: 00380740003746
• UDI-Public: (01)00380740003746
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/04/2025

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: 07/28/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BD., MECH LED,M 16 (ROHS), 7-202564-01, UNKNOWN; BD., MECH LED,M 16 (ROHS), 7-202564-01, UNKNOWN; CABLE, LED3 TO SM ACDC (ROHS), 7-204624-01, UNKNOWN; CABLE, LED3 TO SM ACDC (ROHS), 7-204624-01, UNKNOWN; SM AC/DC CONTROLLER BD, C4 (ROHS), 7-35015731-04,; SM AC/DC CONTROLLER BD, C4 (ROHS), 7-35015731-04,
• Patient Sex: Unknown