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	02/28/2026
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.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer observed falsely elevated sodium (na) and chloride (cl) results for a 39-year-old male patient on an architect c16000 analyzer.The following data was provided (customer¿s normal ranges for na are 136-145 mmol/l, and for cl are 98-110 mmol/l): sample id: (b)(6) initial na result, on (b)(6) 2026, was 161, repeat results were 142 and 142 mmol/l; initial cl result was 122, repeat results were 107 and 108 mmol/l.There was no impact to patient management reported.
Event or Problem Description
The customer observed falsely elevated sodium (na) and chloride (cl) results for a 39-year-old male patient on an architect c16000 analyzer.The following data was provided (customer¿s normal ranges for na are 136-145 mmol/l, and for cl are 98-110 mmol/l): sample id (b)(6) initial na result, on (b)(6) 2026, was 161, repeat results were 142 and 142 mmol/l; initial cl result was 122, repeat results were 107 and 108 mmol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated sodium and chloride results while using ict sample diluent, lot number 83288un25, on an architect c16000 processing module, serial number (b)(6), 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.The customer retested the samples using the same lot of reagent and within range results were generated.In addition, the quality control was performing within the expected ranges.No subsequent issues have been reported.A review of the instrument history revealed no contributing factors described in this complaint.Manufacturing documentation was reviewed and did not identify any issues.A review of labeling and historical data was done, and both were adequate, with no increase in complaint activity.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency 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: 24662943
• Report Number: 3016438761-2026-00152
• Device Sequence Number: 13061015
• 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): 04/14/2026

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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONC ICT DILUENT, 02P32-11, 83288UN25.
• Patient Age: 39 YR
• Patient Sex: Male