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

Catalog Number	02P24-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed sodium results generated on the architect c4000 processing module for multiple samples.The following example data was provided: on (b)(6) 2025, sid (b)(6) (male patient): initial sodium result = 121 mmol/l, repeats = 143 mmol/l and 115 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and performed multiple troubleshooting procedures including cleaning of the cc ict probe.The cleaning of the part resolved the issue.No additional discrepant result issues have been reported since the service activity was completed.Return testing was not completed as returns were not available.An instrument service history review for (b)(6) revealed no additional tickets associated with discrepant/erratic patient results.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of complaint and trending data for the architect system did not identify an increase in complaint activity for the complaint issue.Additionally, a review of complaint and trending data for the cc ict probe did not identify an increase in complaint activity.A review of manufacturing documentation did not identify any nonconformances for the part associated with this complaint.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect c4000 processing module (serial (b)(6) or the cc ict probe were identified.
Event or Problem Description
The customer observed falsely depressed sodium results generated on the architect c4000 processing module for multiple samples.The following example data was provided: on (b)(6) 2025, sid (b)(6) (male patient): initial sodium result = 121 mmol/l, repeats = 143 mmol/l and 115 mmol/l no impact to patient management was reported.

• Brand Name: ARCHITECT C4000 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: 22553411
• Report Number: 3016438761-2025-00418
• Device Sequence Number: 21278222
• Product Code: JJE
• UDI-Device Identifier: 00380740003746
• UDI-Public: (01)00380740003746
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 08/14/2025

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: 02P24-01
• 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: 06/29/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/14/2025
• 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: ICT MODLE, 09D28-04, UNKNOWN
• Patient Sex: Male