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

Catalog Number	02P24-01
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
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 field service engineer(fse) observed smoke and a spark from a wire connecting the smc 1 board and the led board on the architect c4000, serial number (b)(6).The fse had replaced the cpu board and had powered up the module when the issue occurred.The fse powered down and noticed wire was sandwiched between smc board and the metal of the neighboring board causing damage to the wire and sparking.No damage to any board, wire was replaced and the issue resolved no impact to patient management was reported.
Event or Problem Description
The abbott field service engineer(fse) observed smoke and a spark from a wire connecting the smc 1 board and the led board on the architect c4000, serial number (b)(6).The fse had replaced the cpu board and had powered up the module when the issue occurred.The fse powered down and noticed wire was sandwiched between smc board and the metal of the neighboring board causing damage to the wire and sparking.No damage to any board, wire was replaced and the issue resolved no impact to patient management was reported.
Additional Manufacturer Narrative
Service replaced the cable, led1 to smc (rohs)_part number 7-204622-01 on the architect c4000, serial # (b)(6) and saw an electrical spark and smoke when the module was turned back on.The module was immediately turned back off instrument.There was no fire and no injury to personnel reported.While troubleshooting the issue service discovered the electrical spark and smoke was due to the damaged cable, led1 to smc (rohs)_ part number 7-204622-01.Service replaced the cable, led1 to smc (rohs)_part number 7-204622-01 and deemed the part the likely cause.The instrument service history for the architect c4000, serial #c461674 verifies no subsequent issues have been reported related to electrical spark, smoke, or damaged parts after service intervention.A review of trending data associated with the cable, led1 to smc (rohs) _part number 7-204622-01 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.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 observed electrical spark and smoke was limited to the damaged cable, led1 to smc (rohs)_part number 7-204622-01; the damage did not spread to other parts of the module.Based on the investigation, no systemic issue or deficiency was identified.

• Brand Name: ARCHITECT C4000
• 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: 21242953
• Report Number: 3016438761-2025-00060
• Device Sequence Number: 12885619
• Product Code: JJE
• UDI-Device Identifier: 00380740003746
• UDI-Public: (01)00380740003746
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CABLE, LED1 TO SMC (ROHS), 7-204622-01, UNKNOWN.; CABLE, LED1 TO SMC (ROHS), 7-204622-01, UNKNOWN.
• Patient Sex: Unknown