MAUDE Adverse Event Report: Abbott Laboratories Alinity i Processing Module; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03R65-01
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During service of the alinity i processing module, it was observed the wz1 motor cable connectors were corroded and burnt out.Service replaced the wz1 lift motor and wz1 cabling.There were no signs of fire or smoke.There was no impact to patient management or user safety.
Event or Problem Description
During service of the alinity i processing module, it was observed the wz1 motor cable connectors were corroded and burnt out.Service replaced the wz1 lift motor and wz1 cabling.There were no signs of fire or smoke.There was no impact to patient management or user safety.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation evaluated the alinity i processing module, serial number (b)(6).The service representative inspected and observed that the wash zone 1 (wz1) motor cable connectors were corroded and burned.Service replaced the parts, cable, wz #1 lift, ucb (a-35002479-01) and the wash zone lift motor.The cable, wz #1 lift, ucb (a-35002479-01) is considered to resolve the complaint issue.The instrument service history review revealed no complaints.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of tracking and trending did not identify an increase in complaint activity for both the alinity i system and associated part cable, wz #1 lift, ucb with regards to the customer¿s issue.Device history review did not identify any non-conformances or potential non-conformances with the part associated with this complaint.Labeling was reviewed and sufficiently addresses the customer¿s issue.The alinity ci series operations manual provides adequate information regarding electrical hazards and emergency shutdown of the alinity i.The alinity i service documentation provides instruction for the removal, replacement, and verification of the cable, wz #1 lift, ucb (a-35002479-01).Based on the investigation, no systemic issue or deficiency was identified.

• 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 ; +49()6122582960
• MDR Report Key: 50479040
• Report Number: 3016438761-2026-00479
• Device Sequence Number: 10203995
• Product Code: JJE
• UDI-Device Identifier: 00380740137366
• UDI-Public: (01)00380740137366
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170317
• 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): 09/22/2026

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: 08/18/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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