MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C4000 PROCESSING MODULE (INTEGRATED); ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	02P24-40
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated sodium and chloride results generated on a patient when processed on the architect c4000 analyzer.Results were reported to the medical provider.The following data was provided.On (b)(6) 2025, initial sodium results=160 mmol/l, repeat results from another analyzer = 142 mmol/l.On (b)(6) 2025, initial chloride results= 134 mmol/l, repeat results from this analyzer and another analyzer were 109 mmol/l.The customer uses reference range for sodium (135-145 mmol/l) & chloride (98-110 mmol/l).There was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included, no additional patient information was available.
Event or Problem Description
The customer observed a falsely elevated sodium and chloride results generated on a patient when processed on the architect c4000 analyzer.Results were reported to the medical provider.The following data was provided.(b)(6) 2025, initial sodium results=160 mmol/l, repeat results from another analyzer = 142 mmol/l.(b)(6) 2025, initial chloride results= 134 mmol/l, repeat results from this analyzer and another analyzer were 109 mmol/l.The customer uses reference range for sodium (135-145 mmol/l) & chloride (98-110 mmol/l).There was no reported impact to patient management.
Additional Manufacturer Narrative
A complaint investigation was conducted for the architect c4000, serial number (b)(6).The field service representative (fsr) observed the solenoid valves were leaking when troubleshooting the issue.The waste fittings kit (rohs)_ was cleaned out and drained and deemed the cause for the issue.The service history of the (b)(6) found no additional discrepant sodium and chloride results were reported after the current event was identified.A review of tracking and trending did not identify any trends for the architect c4000 instrument with regards 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 our investigation, no systemic issue or deficiency was identified for the architect c4000, serial number (b)(6) or the waste fittings kit.

• Brand Name: ARCHITECT C4000 PROCESSING MODULE (INTEGRATED)
• 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: 23609020
• Report Number: 3016438761-2025-00679
• Device Sequence Number: 13241269
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: 02P24-40
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2020
• 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: WASTE FITTINGS KIT (ROHS), 7-203775-01, UNKNOWN.; WASTE FITTINGS KIT (ROHS), 7-203775-01, UNKNOWN.
• Patient Sex: Unknown