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

Catalog Number	03R67-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed depressed sodium when processing on alinity c processing module.Sid (b)(6)(male 81 years old) generated sodium of 118 mmol/l that repeated 141 mmol/l.The repeated result matched patient historical result and was reported out of lab.The customer normal range: sodium 135-145 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) performed quarterly maintenance on the alinity c processing module, serial number (b)(6), found the external waste tubing was obstructed, causing back pressure at the hcw pump, and cleaned the lines.However, a definitive part was not identified as cause of the issue, therefore, the alinity c, serial number (b)(6) was deemed the cause.The module function was verified with a control run.The service history of the alinity c, serial number (b)(6) returned no additional complaint tickets for the module generating discrepant sodium patient results or message code 3062.A review of tracking and trending did not identify any trends for the alinity c processing module with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and was found to address the customer reported issue.Based on our investigation, no systemic issue or deficiency was identified with the alinity c processing module, serial number (b)(6).

• Brand Name: Alinity c 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: 50408415
• Report Number: 3016438761-2026-00464
• Device Sequence Number: 15746424
• Product Code: JJE
• UDI-Device Identifier: 00380740137380
• UDI-Public: (01)00380740137380
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170316
• 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): 09/30/2026

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: 03R67-01
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2018
• 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 Age: 81 YR
• Patient Sex: Male