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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed sodium results on the architect c16000 processing module for one patient.The following results were provided: sid: (b)(6), initial sodium result= 115.4 mmol/l; repeat result on au5800 platform= 136 mmol/l; repeat on architect after recalibration= 137.6 mmol/l.Reference ranges: abbott system: 136 - 145 mmol/l, au5800: 135-145 mmol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
Section a patient information: refer to section b5 for complete patient information.The field service representative (fsr) performed troubleshooting on the architect c16000 processing module, serial number: (b)(6) and observed that the washer, cuvette 16 was clogged.The washer, cuvette 16 (rohs) was cleaned and deemed the cause of the issue.The module function was verified with a control/precision run.The instrument service history for the (b)(6) verifies no subsequent issues have been reported related to discrepant patient results after the current complaint was reported.A review of trending data associated with the washer, cuvette 16 (rohs) did not identify any trends.A review of tracking and trending did not identify any trends for the architect c16000 processing module with regard to the customer reported event.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect c16000 processing module for serial (b)(6) or the washer, cuvette 16 (rohs) were identified.

• 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 ; +49()6122582960
• MDR Report Key: 50869034
• Report Number: 3016438761-2026-00527
• Device Sequence Number: 18486793
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 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: 09/03/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2019
• 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
• Patient Sex: Unknown