MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY I PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03R65-01
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The field service engineer (fse) was onsite inspecting the alinity i processing module, and observed the following instrument error messages: 0148 ¿ initialization error, 3316 ¿ vacuum initialization failed, 3320 ¿ vacuum system failed.And 0148 with error code, 5579-reagent supply center initialization failed, 5654-reagent carousel monitoring error, 5674-reagent carousel operation failed, 5007-d708-reagent carousel servo drive 5760-g005.Both carousel and vacuum pump were making some noise during initialization.The fse first replaced the servo drive.The fse inspected the carousel for any obstruction; however, it was moving smoothly but noticed one wheel was gliding instead of rotating.The fse replaced the wheel and rebuilt the vacuum pump with the vacuum repair kit.The fse tried to recalibrate the reagent carousel and the capacitor blew causing the plug to be charred and damaged.The fse observed visible smoke from the capacitor.No impact to patient management or user safety was reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and replaced the circuit board, lower controller, which resolved the issue.The instrument service history for the alinity i processing module verifies no subsequent complaints have been reported related to charring / smoke since the service activity was completed.A review of complaint and trending data for the alinity i processing module did not identify any similar issues as described in this complaint.Additionally, review of complaint and trending data associated with the circuit board, lower controller did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances or potential non-conformances associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the alinity i processing module for serial (b)(6) or the circuit board, lower controller were identified.
Event or Problem Description
The field service engineer (fse) was onsite inspecting the alinity i processing module, and observed the following instrument error messages: 0148 ¿ initialization error, 3316 ¿ vacuum initialization failed, 3320 ¿ vacuum system failed.And 0148 with error code, 5579-reagent supply center initialization failed, 5654-reagent carousel monitoring error, 5674-reagent carousel operation failed, 5007-d708-reagent carousel servo drive, 5760-g005.Both carousel and vacuum pump were making some noise during initialization.The fse first replaced the servo drive.The fse inspected the carousel for any obstruction, however it was moving smoothly, but noticed one wheel was gliding instead of rotating.The fse replaced the wheel and rebuilt the vacuum pump with the vacuum repair kit.The fse tried to recalibrate the reagent carousel and the capacitor blew causing the plug to be charred and damaged.The fse observed visible smoke from the capacitor.No impact to patient management or user safety was reported.

• Brand Name: ALINITY I 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: 25348419
• Report Number: 3016438761-2026-00299
• Device Sequence Number: 18825558
• Product Code: JJE
• UDI-Device Identifier: 00380740137366
• UDI-Public: (01)00380740137366
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K170317
• 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): 07/15/2026

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: 03R65-01
• 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: 05/21/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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