MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY CI-SERIES SYSTEM CONTROL MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03R70-01
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The field service representative (fsr) observed smoke coming from the back of the monitor for the alinity ci-series system control module.While onsite and working on another analyzer, the customer cycled power to system.Upon reboot, customer reported screen went blank.Fsr noticed smoke coming from back of the monitor.Fsr unplugged and removed the monitor from the system promptly.When removing the monitor and cable, damage to the cable was noticed.The monitor was replaced but the screen stayed blank.Replaced uic.Screen came back normally.No impact to user safety/patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
When investigating the source of the smoke, service found that the electrical cord of the alnty monitor was damaged.The alnty monitor was replaced and deemed the cause for the observed smoke.A review of the alinity ci, serial # (b)(6) service history, revealed no additional issues of smoke or damage to the alnty monitor on the (b)(6).The smoke and damage observed was limited to the electrical cord of the alnty monitor, the smoke and damage did not spread to other parts of the module.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 was identified.
Event or Problem Description
The field service representative (fsr) observed smoke coming from the back of the monitor for the alinity ci-series system control module.While onsite and working on another analyzer, the customer cycled power to system.Upon reboot, customer reported screen went blank.Fsr noticed smoke coming from back of the monitor.Fsr unplugged and removed the monitor from the system promptly.When removing the monitor and cable, damage to the cable was noticed.The monitor was replaced but the screen stayed blank.Replaced uic.Screen came back normally.No impact to user safety/patient management was reported.

• Brand Name: ALINITY CI-SERIES SYSTEM CONTROL 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: 21172240
• Report Number: 3016438761-2025-00036
• Device Sequence Number: 4538695
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: 03R70-01
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2018
• 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