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	07/31/2025
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.
Event or Problem Description
The customer observed falsely elevated sodium result generated by the architect c16000 processing module for a patient.The sample was repeated, and the result was within the normal range.The following data was provided: customer¿s reference range: 135 to 145 mmol/l.Initial sodium result = 196 mmol/l; repeat result = 139 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
The abbott field service representative (fsr) reviewed the instrument logs and recommended replacement of the aero c8k 1ml syr.The customer replaced the part and the issue was resolved.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.The instrument service history for the (b)(6) verifies no subsequent issues have been reported related to discrepant patient results after service intervention.Trending review determined normal complaint activity for the issue for the products.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no deficiency for the architect c16000, serial # (b)(6) or the aero c8k 1ml syr was identified.
Event or Problem Description
The customer observed falsely elevated sodium result generated by the architect c16000 processing module for a patient.The sample was repeated, and the result was within the normal range.The following data was provided: customer¿s reference range: 135 to 145 mmol/l.Initial sodium result = 196 mmol/l; repeat result = 139 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: 22738281
• Report Number: 3016438761-2025-00461
• Device Sequence Number: 7125365
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: 07/31/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2017
• 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: CC1CT SAMP DIL, 01E48-20, UNKNOWN.; CC1CT SAMP DIL, 01E48-20, UNKNOWN.
• Patient Sex: Unknown