MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C4000; 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	12/30/2024
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 decreased sodium results generated from architect c4000 processing module for one patient.The results provided were: initial=118 meq/l/repeated on another archtiect =138.0 meq/l /repeated on architect (b)(6) =138, 135, 138, 138 and 138 meq/l there was no reported impact to patient management.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the analyzer determined the cc cuv dry tip list# 09d51-02) was dirty, the replacement of cc cuv dry tip which resolved the issue.The instrument service history review revealed no additional tickets associated with discrepant/erratic patient results.There were no 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 c4000 processing module did not identify any similar issues as described in this complaint.Additionally review of complaint and trending data associated with the cc cuv dry tip list# 09d51-02) did not identify an increase in complaint activity.A review of historical data revealed did not increased in complaint activities, systemic issues, or related nonconformances.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for either the architect c4000 processing module, serial number (b)(6), or the cuv dry tip.
Event or Problem Description
The customer observed falsely decreased sodium results generated from architect c4000 processing module for one patient.The results provided were: initial=118 meq/l/repeated on another archtiect =138.0 meq/l /repeated on architect (b)(6) =138, 135, 138, 138 and 138 meq/l there was no reported impact to patient management.

• Brand Name: ARCHITECT C4000
• 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: 21169958
• Report Number: 3016438761-2025-00035
• Device Sequence Number: 9494167
• Product Code: JJE
• UDI-Device Identifier: 00380740003746
• UDI-Public: (01)00380740003746
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: EXEMPT
• 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): 02/06/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2010
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONC ICT DILUENT, 02P32-11,; CONC ICT DILUENT, 02P32-11,
• Patient Sex: Unknown