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	06/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete entry for section a1 - patient identifier: (b)(6).Complete entry for section e1 - phone number: (b)(6).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 and potassium on the architect c4000 processing module for one patient.The following results were provided (reference range chloride 98-107 mmol/l; potassium 3.5 ¿ 5.1 mmol/l; sodium 136 ¿ 145 mol/l): sid (b)(6), (b)(6) 2025, initial potassium result= 2.4 mmol/l; (b)(6) 2025, repeat potassium results= 3.7 mmol/l, 3.6 mmol/l; (b)(6) 2025, initial sodium result= 101 mmol/l; (b)(6) 2025, repeat sodium results= 138 mmol/l, 138 mmol/l, 138 mmol/l, 137 mmol/l, 137 mmol/l, 137 mmol/l.Update, additional information was provided on 18jun2025.Sid (b)(6), results from i-stat: sodium= 137 mmol/l; potassium= 3.5 mmol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
Update to section b3 - date of event from 6/16/2025 to 6/14/2025.The field service representative (fsr) inspected the architect c4000, serial number (b)(6), performed troubleshooting and replaced the tubing, ict pinch valve (rohs) and nozzle c4 #1, #4, #5 (rohs).The replacement of the tubing, ict pinch valve (rohs) and nozzle c4 #1, #4, #5 (rohs) resolved the issue.Return testing was not completed as returns were not available.The service history of the (b)(6) verifies no subsequent issues have been reported related to false depressed patient results.A review of tracking and trending of the architect c4000 did not identify an increase of complaint activity associated with the complaint issue.Additionally, a review of tracking and trending for the tubing, ict pinch valve (rohs) and nozzle c4 #1, #4, #5 (rohs) did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect c4000, serial number (b)(6) or the tubing, ict pinch valve (rohs) was identified.
Event or Problem Description
The customer observed falsely depressed sodium and potassium on the architect c4000 processing module for one patient.The following results were provided (reference range chloride 98-107 mmol/l; potassium 3.5 ¿ 5.1 mmol/l; sodium 136 ¿ 145 mol/l): sid (b)(6), (b)(6) 2025, initial potassium result= 2.4 mmol/l; (b)(6) 2025, repeat potassium results= 3.7 mmol/l, 3.6 mmol/l; (b)(6) 2025, initial sodium result= 101 mmol/l; (b)(6) 2025, repeat sodium results= 138 mmol/l, 138 mmol/l, 138 mmol/l, 137 mmol/l, 137 mmol/l, 137 mmol/l.Update, additional information was provided on 18jun2025.Sid (b)(6), results from i-stat: sodium= 137 mmol/l; potassium= 3.5 mmol/l.There was no impact to patient management 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: 22358631
• Report Number: 3016438761-2025-00369
• Device Sequence Number: 12925504
• Product Code: JJE
• UDI-Device Identifier: 00380740003746
• UDI-Public: (01)00380740003746
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 07/10/2025

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: 06/16/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2018
• 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: NOZZLE C4 #1, #4, #5 (ROHS), 7-205228-02, UNKNOWN; NOZZLE C4 #1, #4, #5 (ROHS), 7-205228-02, UNKNOWN; TUBING, ICT PINCH VALVE (ROHS), 7-204068-01, UNKNO; TUBING, ICT PINCH VALVE (ROHS), 7-204068-01, UNKNO
• Patient Sex: Unknown