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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Completed information for section a1 patient identifier: sids (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely elevated potassium result generated on the architect c4000 processing module for multiple samples.The following data was provided (customer provided normal range: 3.5 to 5.1 mmol/l): (b)(6) 2025, sid (b)(6) : initial result = 6.65 mmol/l, repeat = 4.83 mmol/l, (b)(6) 2025, sid (b)(6) : initial result = 6.88 mmol/l, repeat = 5.03 mmol/l, (b)(6) 2025, sid (b)(6): initial result = 6.68 mmol/l, repeat = 4.94 mmol/l.No impact to patient management was reported.
Event or Problem Description
The customer reported a falsely elevated potassium result generated on the architect c4000 processing module for multiple samples.The following data was provided (customer provided normal range: 3.5 to 5.1 mmol/l): (b)(6) 2025, sid (b)(6): initial result = 6.65 mmol/l, repeat = 4.83 mmol/l, (b)(6) 2025, sid (b)(6): initial result = 6.88 mmol/l, repeat = 5.03 mmol/l, (b)(6) 2025, sid (b)(6): initial result = 6.68 mmol/l, repeat = 4.94 mmol/l , no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated potassium results while using architect ict sample diluent, lot number 01743un25, on the architect c4000 processing module, serial number (b)(6), included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.The customer retested the sample using the same lot for the initial testing and the retesting and qc (quality control) was in range.No subsequent issues have been reported.A search for similar complaints did not identify an increase in complaint activity for the complaint lot or list number.Device history record review did not identify any non-conformances, potential non-conformances, or deviations with the complaint lot.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect c4000 processing module, serial number (b)(6), and architect ict sample diluent lot number 01743un25, was identified.

• 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: 23907296
• Report Number: 3016438761-2025-00771
• Device Sequence Number: 13244877
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2018
• 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: ICT INT REF(2X2L), 01E49-21, 01743UN25
• Patient Sex: Unknown