MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C8000; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01G06-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
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 decreased sodium result generated on the architect c8000 processing module.Results provided: 111 / 140 mmol/l (normal range: 135-145 mmol/l).No impact to patient management was reported.
Additional Manufacturer Narrative
The customer replaced the architect the 1 ml syringes, which resolved the issue.There were no additional discrepant results reported on the architect c8000, serial number (b)(6), after the parts were replaced.Return testing was not completed as returns were not available.A review of the architect (b)(6) instrument service history, identified no contributing factors to the discrepant result, nor did it identify any additional erratic or discrepant results reported.A review of the architect clinical chemistry systems found all erratic results were below the upper control limit.No trends or similar issues for discrepant results as described in this ticket were identified.A review of historical data for the parts replaced with this complaint, revealed no trends, systemic issues, or nonconformances.A review of labelling adequately addresses sample results observed problems for erratic / discrepant results, including, but not limited to the troubleshooting performed by the customer.Manufacturing documentation for the likely causes did not identify any issues associated with the complaint issue.Based on the investigation no product deficiency was identified for either the architect c8000, serial number (b)(6), or the parts replaced.
Event or Problem Description
The customer reported a falsely decreased sodium result generated on the architect c8000 processing module.Results provided: 111 / 140 mmol/l (normal range: 135-145 mmol/l).No impact to patient management was reported.

• Brand Name: ARCHITECT C8000
• 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: 21871477
• Report Number: 3016438761-2025-00234
• Device Sequence Number: 7803608
• Product Code: JJE
• UDI-Device Identifier: 00380740023089
• UDI-Public: (01)00380740023089
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/30/2025

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: 01G06-01
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2005
• 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, 46187UN23; CONC ICT DILUENT, 02P32-11, 46187UN23
• Patient Sex: Unknown