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	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed sodium (na) results generated on the architect c16000 instrument.The following data was provided: sid (b)(6).Na initial result 105 mmol/l, rerun 140 and 141 mmol/l.Sid (b)(4).Na initial result 119 mmol/l, rerun 140 and 141 mmol/l.Sid (b)(6) na initial result 120 mmol/l, rerun 139 and 139 mmol/l.Sid (b)(6).Na initial result 107 mmol/l, rerun 142 and 142 mmol/l.Normal ranges in this lab: na 136-145 mmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
This report is being filed on an international product, list number 03l77 that has a similar product distributed in the us, list number 03l77, and 510k exempt.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.A1 patient identifier: sample id's are (b)(6).
Additional Manufacturer Narrative
The field service representative performed troubleshooting on the architect c16000 processing module, serial number (b)(6) and found that all the results were in cuvette #297.The aero cuvette segment was replaced, which resolved the issue.A review of the (b)(6) module service history revealed no additional complaint tickets of falsely depressed sodium patient results after the current issue was identified.A review of tracking and trending of the architect c16000 did not identify an increase in complaint activity associated with the complaint issue.A review of tracking and trending for the aero cuvette segment did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect c16000 processing module, serial number (b)(6) or the aero cuvette segment was identified.
Event or Problem Description
The customer observed falsely depressed sodium (na) results generated on the architect c16000 instrument.The following data was provided: sid (b)(6).Na initial result 105 mmol/l, rerun 140 and 141 mmol/l.Sid (b)(6).Na initial result 119 mmol/l, rerun 140 and 141 mmol/l.Sid (b)(6).Na initial result 120 mmol/l, rerun 139 and 139 mmol/l.Sid (b)(6).Na initial result 107 mmol/l, rerun 142 and 142 mmol/l.Normal ranges in this lab: na 136-145 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: 23500456
• Report Number: 3016438761-2025-00660
• Device Sequence Number: 18368797
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• 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): 12/11/2025

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: 10/30/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2014
• 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