MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C4000 PROCESSING MODULE (INTEGRATED); ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	02P24-40
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a1 patient identifier is sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed sodium on the architect c4000 processing module for a 39-year-old male.The following results were provided (reference range 137-147 mmol/l): sid (b)(6), initial sodium result= 103 mmol/l; repeat result (automatic)= 111 mmol/l; repeat result on same sample, sample instrument= 138 mmol/l; repeat result on another instrument (b)(6) = 137 mmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the architect c4000 serial number (b)(6) and the architect ict sample diluent.As part of troubleshooting the patient samples were rerun with the same reagent lot three times, with one run on a separate instrument, which generated acceptable results.Quality controls were within range at the time of the incident.A review of tracking and trending did not identify any trends 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 sufficiently addresses the customer¿s issue.Based on our investigation, no systemic issue or deficiency was identified for the architect c4000 serial number (b)(6) or the architect ict sample diluent.
Event or Problem Description
The customer observed falsely depressed sodium on the architect c4000 processing module for a 39-year-old male.The following results were provided (reference range 137-147 mmol/l): sid (b)(6), initial sodium result= 103 mmol/l; repeat result (automatic)= 111 mmol/l; repeat result on same sample, sample instrument= 138 mmol/l; repeat result on another instrument (c402434)= 137 mmol/l no impact to patient management was reported.

• Brand Name: ARCHITECT C4000 PROCESSING MODULE (INTEGRATED)
• 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: 23478605
• Report Number: 3016438761-2025-00653
• Device Sequence Number: 13325041
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 02P24-40
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/14/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONC ICT DILUENT, 02P32-11, 60139UN25; CONC ICT DILUENT, 02P32-11, 60139UN25
• Patient Age: 39 YR
• Patient Sex: Male