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	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed depressed sodium when processing on alinity c processing module.On (b)(6) 2026, sid (b)(6) generated sodium of 102 mmol/l.The result was reported out of lab and patient was referred to intensive care unit.No treatment was given.On (b)(6) 2026, the same patient generated sodium of 140 mmol/l, matching historical patient sodium of 140 mmol/l.The customer normal sodium range is >125 mmol/l.No impact on patient management was reported.
Additional Manufacturer Narrative
The alinity c processing module was inspected, and the ict probe was replaced which resolved the issue.The module function was verified with a control run.An instrument service history review for serial number ac06925 revealed no additional discrepant sodium results reported after the current ticket was reported.A review of tracking and trending for the ict probe did not identify any trends.A review of tracking and trending for the alinity c processing module did not identify any trends related to the complaint issue.A review of manufacturing documentation did not identify any non-conformances or potential non-conformances for the ict probe.Labeling was reviewed and found to adequately address the complaint issue.Based on the investigation, no systemic issue or deficiency of the alinity c processing module serial number ac06925 or the ict probe was identified.

• 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: 50356479
• Report Number: 3016438761-2026-00463
• Device Sequence Number: 10111570
• Product Code: JJE
• UDI-Device Identifier: 00380740137380
• UDI-Public: (01)00380740137380
• Combination Product (Y/N): N
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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: 09/08/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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: 88 YR
• Patient Sex: Male