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	05/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The field service representative (fsr) reported that during startup of the alinity i processing module, smoke and an acrid odor were observed coming from the servo rack.The instrument was immediately powered down, and the smoke subsided.Staff were instructed not to power on the analyzer until service was completed.Upon inspection, a component on the 25-amp servo board was found to be melted.The 25-amp servo board was replaced, and the issue was resolved.There was no impact to patient management, user safety, or facility damage reported.No injuries were reported.
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 field service representative (fsr) reported that during startup of the alinity i processing module, smoke and an acrid odor were observed coming from the servo rack.The instrument was immediately powered down, and the smoke subsided.Staff were instructed not to power on the analyzer until service was completed.Upon inspection, a component on the 25-amp servo board was found to be melted.The 25-amp servo board was replaced, and the issue was resolved.There was no impact to patient management, user safety, or facility damage reported.No injuries were reported.
Additional Manufacturer Narrative
The abbott field service representative (fsr) inspected the instrument and found the charring/melting on the servo driver 25 amp.The fsr replaced the servo driver 25 amp which resolved the issue.There was no fire seen nor any additional damage to the instrument and there was no injury to personnel reported.A review of the instrument service history for serial number (b)(6) revealed no additional issues of charring/melting or smoke related to the servo driver 25 amp.A review of complaint and trending data for the alinity i processing module did not identify an increase in complaint activity associated with the complaint issue.Additionally, a review of complaint and trending data for the servo driver 25 amp did not identify any trends.A review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency was identified for the alinity i processing module, serial number (b)(6), or the servo driver 25 amp.

• 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: 25537963
• Report Number: 3016438761-2026-00336
• Device Sequence Number: 9359093
• Product Code: JJE
• UDI-Device Identifier: 00380740137366
• UDI-Public: (01)00380740137366
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: 05/29/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2020
• 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