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

Catalog Number	01G06-11
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
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 has been included.No additional patient details are available.
Event or Problem Description
The customer reported falsely decreased sodium generated from architect analyzer and provided the following data: the initial result was 105 mmol/l and the repeat result was 137 mmol/l (customer normal range 135-145 mmol/l).Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument, performed multiple troubleshooting procedures and resolved the issue by replacing the clogged tubing.A review of instrument service history for (b)(6) revealed no additional discrepant result issues have been reported since the service activity was completed.There were no service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of complaint and trending data for the architect c8000 processing module did not identify any similar issues as described in this complaint.Additionally, a review of complaint and trending data associated with the tubing did not identify an increase in complaint activity.The device history record was reviewed, and no non-conformances or deviations were identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency was identified for the architect c8000 processing module, serial number (b)(6), or the tubing.
Event or Problem Description
The customer reported falsely decreased sodium generated from architect analyzer and provided the following data: the initial result was 105 mmol/l and the repeat result was 137 mmol/l (customer normal range 135-145 mmol/l) per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.

• Brand Name: ARCHITECT C8000 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: 23244771
• Report Number: 3016438761-2025-00591
• Device Sequence Number: 10425460
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: (01)00380740000509
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: 01G06-11
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2019
• 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
• Patient Sex: Unknown