MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C16000 PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03L77-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 reported a falsely elevated potassium result generated by the architect c16000 processing module for a patient.The result was not released out of the laboratory.The sample was repeated, yielding a result within the normal range.The following data was provided: customer¿s normal reference range: 3.5 to 5.7 mmol/l initial potassium result = 7.1 mmol/l repeat potassium result = 5.7 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 35855un25 and architect ict reference solution lot number 29419un24, on the architect c16000 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 lots, and no increase in complaint activity was identified for list numbers 01e49 and 02p32.Device history record review did not identify any non-conformances, potential non-conformances, or deviations with the complaint lots.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect c16000 processing module, serial number (b)(6), and architet ict sample diluent lot number 35855un25 or architect ict reference solution lot number 29419un24, was identified.
Event or Problem Description
The customer reported a falsely elevated potassium result generated by the architect c16000 processing module for a patient.The result was not released out of the laboratory.The sample was repeated, yielding a result within the normal range.The following data was provided: customer¿s normal reference range: 3.5 to 5.7 mmol/l.Initial potassium result = 7.1 mmol/l.Repeat potassium result = 5.7 mmol/l.No impact to patient management was reported.

• Brand Name: ARCHITECT C16000 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: 23337013
• Report Number: 3016438761-2025-00610
• Device Sequence Number: 7956870
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/24/2025

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: 03L77-01
• 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: 10/11/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2017
• 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, 35855UN25; CONC ICT DILUENT, 02P32-11, 35855UN25; ICT INT REF(2X2L), 01E49-21, 29419UN24
• Patient Sex: Unknown