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	11/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely elevated potassium result generated by the architect c16000 processing module for an 80-year-old male patient diagnosed with respiratory tract infection.The sample was repeated, and the results were within the normal range.The following data was provided: customer¿s reference range: 3.5 to 5.3 mmol/l sid (b)(6): initial potassium result = 7.79 mmol/l, repeat results = 4.45 mmol/l and 4.22 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.This report is being filed on an international product, list number 03l77-01, that has the same product distributed in the us, list number 03l77, that is 510k exempt.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the architect c16000 processing module, serial number (b)(6) and observed a crystalized substance on the sample probe.The fsr resolved the issue by cleaning the sample probe and repeating the sample.The instrument service history review revealed no additional service tickets associated with discrepant/erratic patient results.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of tracking and trending of the architect c16000 processing module did not identify an increase in complaint activity associated with the complaint issue.A review of tracking and trending for the sample probe did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Based on the available information, no systemic issue or deficiency of the architect c16000 processing module, serial number (b)(6) or the sample probe was identified.
Event or Problem Description
The customer reported a falsely elevated potassium result generated by the architect c16000 processing module for an 80-year-old male patient diagnosed with respiratory tract infection.The sample was repeated, and the results were within the normal range.The following data was provided: customer¿s reference range: 3.5 to 5.3 mmol/l.Sid (b)(6): initial potassium result = 7.79 mmol/l.Repeat results = 4.45 mmol/l and 4.22 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: 23693564
• Report Number: 3016438761-2025-00695
• Device Sequence Number: 9193621
• 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): 12/10/2025

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: 11/23/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2019
• 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, 61255UN25.; CONC ICT DILUENT, 02P32-11, 61255UN25.
• Patient Age: 80 YR
• Patient Sex: Male