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	05/12/2025
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 depressed sodium results on the architect c16000 processing module for one patient.The sample was repeated with higher results.The following data was provided: initial result = 99.5 mmol/l.Repeat result = 138.36 mmol/l.Reference range = 137-147 mmol/l.No impact to patient management was reported.
Event or Problem Description
The customer observed falsely depressed sodium results on the architect c16000 processing module for one patient.The sample was repeated with higher results.The following data was provided: initial result = 99.5 mmol/l.Repeat result = 138.36 mmol/l.Reference range = 137-147 mmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed sodium results on the architect c16000 processing module, serial number (b)(6), when using architect concentrated ict diluent ln 02p32-11 lot 75307un24.The investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Trending review determined there was no increased complaint activity for the issue.Return testing was not completed as returns were not available.Return testing was not completed as return was not available.As part of troubleshooting customer performed carryover testing.The outcome confirmed that there was third-party reagent interference and added smart wash.The sample was repeated using the same lot of reagents and gave an acceptable result.The quality control was performing within the expected ranges.Manufacturing documentation was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and the complaint investigation completed, no systemic issue or deficiency with the conc ict diluent, list number 02p32-11, on the architect c16000 processing module, serial number (b)(6), was 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 ; 6122582960
• MDR Report Key: 22078658
• Report Number: 3016438761-2025-00311
• Device Sequence Number: 9501516
• 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): 06/02/2025

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: 05/12/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2017
• 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: CONC ICT DILUENT, 02P32-11, 75307UN24; CONC ICT DILUENT, 02P32-11, 75307UN24
• Patient Sex: Unknown