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	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated sodium results generated on an alinity c processing module for three samples, however only provided two of the patient results.The following data was provided (normal reference range 136-145 mmol/l): sid: (b)(6) initial result = 169 mmol/l, rerun on other instrument = 142 mmol/l.Sid (b)(6) initial result = 177 mmol/l, rerun on other instrument = 143 mmol/l.There was no impact to patient management.
Additional Manufacturer Narrative
Section a patient information: refer to section b5 for complete patient information.A complaint investigation was conducted for the alinity c processing module, serial number (b)(6) to address the customer¿s observation of falsely elevated results.The customer performed the recommended troubleshooting, that included flushing the wash cup and ict module, washing the cuvettes and recalibration of pipettors without issue resolution and the field service representative (fsr) was dispatched.The fsr inspected the alinity c processing module and replaced the worn 1ml syringe resolving the issue.The 1ml syringe was determined to be the cause.No additional result issue has been reported since the service activity was completed.The instrument service history review revealed no additional tickets associated with discrepant/erratic patient results.A review of tracking and trending did not identify any trends regarding the event.Labeling was found to be adequate for the complaint issue.Based on our investigation, no systemic issue or deficiency 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 ; 6122582960
• MDR Report Key: 25173884
• Report Number: 3016438761-2026-00270
• Device Sequence Number: 10182354
• Product Code: JJE
• UDI-Device Identifier: 00380740137380
• UDI-Public: (01)00380740137380
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 05/14/2026

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: 04/27/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1ML SYRINGE, 09D41-03, N/A
• Patient Sex: Unknown