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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient identifier reached maximum character limit, the full id is (b)(6).Section a patient information: refer to section b5 for complete patient information.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed elevated sodium when processing on alinity c processing module.The customer observed elevated sodium results for samples that were repeated using spare samples for the same patient generating normal results of 137-141 mmol/l.On (b)(6) 2026, id (b)(6) (72-year-old female) generated sodium of 162, 161 mmol/l that repeated with different spare sample of 137 mmol/l on the same alinity c processing module.The same sample, sid (b)(6), was also tested on another instrument with sodium of 162 mmol/l for troubleshooting.No abnormal results were reported to clinicians.No impact to patient management was reported.

• 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: 25772931
• Report Number: 3016438761-2026-00379
• Device Sequence Number: 20268128
• 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,Followup
• Report Date (Section B): 09/28/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Supplement Date Received by Manufacturer: 07/20/2026; 09/09/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 07/29/2026; 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2018
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALINITY C PROC MOD, 3R67-01, (B)(6)
• Patient Age: 72 YR
• Patient Sex: Female