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	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
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.Additional patient details are not available.
Event or Problem Description
The customer observed the architect c4000 printout showed the incorrect patient demographics, when compared with information on barcode label for a sample.The barcode label contains the correct patient demographics.Patient 1: sid (b)(6) run (b)(6) 2025 with patient id (b)(6) initials (b)(6) for iron test.This patient was hospitalized a month ago and has not been back for anything since.Patient 2: correct patient id (b)(6) with patient initials ll which also had an iron test customer manually ordered test for correct patient id (b)(6) and reported the results with correct demographics.No impact to patient management was reported.
Event or Problem Description
The customer observed the architect c4000 printout showed the incorrect patient demographics, when compared with information on barcode label for a sample.The barcode label contains the correct patient demographics.Patient 1: sid (b)(6) run (b)(6) 2025 with patient id (b)(6) initials (b)(6) for iron test.This patient was hospitalized a month ago and has not been back for anything since.Patient 2: correct patient id (b)(6) with patient initials (b)(6) which also had an iron test.Customer manually ordered test for correct patient id (b)(6) and reported the results with correct demographics.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information section h4 - device mfr date.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The customer observed an issue where the architect system report demographics did not match the demographics on the specimen barcode label on the architect c4000 intgr, serial number (b)(6).The search for similar complaints found additional complaints related to the text query, however, there have been no subsequent tickets opened for report demographics not matching the demographics on the specimen barcode label.Review of tracking and trending did not identify any trends related to the complaint issue.Device history review did not identify any nonconformances, potential nonconformances or deviations associated with the complaint lot number or issue.Labeling was reviewed and was found to adequately address the current issue.Based on the investigation, no systemic issue or deficiency of the architect c4000 intgr, serial number (b)(6) or the architect system software v9.45 was identified.

• 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: 23873054
• Report Number: 3016438761-2025-00757
• Device Sequence Number: 4552761
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/15/2026

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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2017
• 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
• Patient Sex: Unknown