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	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed alinity c sodium results for one 66-year-old male patient on the alinity serial number (b)(6).The sample was repeated with higher results.The following data was provided: sid: (b)(6) processed on (b)(6) 2026.Initial result processed on alinity c serial number, (b)(6), sodium = 118 repeat processed on (b)(6) and (b)(6) = 141 and 142 mmol/l.Sodium reference range: 136-145 mmol/l no impact to patient management was reported.
Event or Problem Description
The customer observed falsely depressed alinity c sodium results for one 66-year-old male patient on the alinity serial number ac03094.The sample was repeated with higher results.The following data was provided: sid: (b)(6)processed on (b)(6)2026 initial result processed on alinity c serial number, (b)(6), sodium = 118 repeat processed on (b)(6)and ac05130 = 141 and 142 mmol/l sodium reference range: 136-145 mmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.All available patient information was provided, no additional patient information was available.
Additional Manufacturer Narrative
The field service representative (fsr) discovered that the ict probe was dirty/contaminated.Service replaced the ict probe and deemed the part the cause of the issue.The issue was considered resolved with the replacement of the ict probe.The module function was verified with a control run.A review of the alinity c, serial number (b)(6)service history, revealed no additional discrepant patient results reported after the current ticket was reported.A review of tracking and trending of the ict probe did not identify any trends associated with the complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Device history record review did not show any non-conformances or potential non-conformances for the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the alintiy c processing module, serial number (b)(6)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: 50871826
• Report Number: 3016438761-2026-00530
• Device Sequence Number: 13447536
• Product Code: JJE
• UDI-Device Identifier: 00380740137380
• UDI-Public: (01)00380740137380
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/23/2026

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: 09/09/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ALNTY C ICT SAMPLE DILU, (b)(6),; ALNTY C ICT SAMPLE DILU, 07P53-20,
• Patient Age: 66 YR
• Patient Sex: Male