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	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
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 customer reported no display on the monitor on the alinity ci-series processing module.The customer found the hdmi port appeared to be heat-deformed/showing signs of having melted.No impact to patient management or user safety was reported.
Event or Problem Description
The customer reported no display on the monitor on the alinity ci-series processing module.The customer found the hdmi port appeared to be heat-deformed/showing signs of having melted.No impact to patient management or user safety was reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and found the hdmi port showed evidence of melting.The alinity, uic h was replaced to resolve the issue.Issue resolution was confirmed with verification procedures and passing qc runs.Instrument service history was reviewed and found no additional tickets associated with smoke.Device history review of the alinity, uic h did not identify any non-conformances or potential non-conformances.A complaint search for the alinity, uic h did not identify any trends related to the complaint issue.A review of tracking and trending of the alinity ci-series scm did not identify any trends with regards to the complaint issue.Labeling was reviewed and adequately addressed the issue.Based on the investigation, no systemic issue or deficiency was identified for the alinity ci-series scm, (b)(6), or the alinity, uic h.Corrected information in section a.As there was no patient involvement or impact to user safety, the fields were update to na.

• 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: 24456354
• Report Number: 3016438761-2026-00109
• Device Sequence Number: 10148643
• Product Code: JJE
• UDI-Device Identifier: 00380740137410
• UDI-Public: (01)00380740137410
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K230790
• 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): 03/17/2026

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: 03R70-01
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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