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	06/04/2025
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 on the architect c4000 processing module for one patient that was not release out of the laboratory.The following results were provided (reference range 136 to 145 mmol/l): (b)(6) 2025, sid (b)(6), initial sodium result= 114 mmol/l; repeat result= 141 mmol/l; repeat result (i-stat)= 140 mmol/l.There was no impact to patient management reported.
Event or Problem Description
The customer observed falsely depressed sodium on the architect c4000 processing module for one patient that was not release out of the laboratory.The following results were provided (reference range 136 to 145 mmol/l): (b)(6) 2025, sid (b)(6), initial sodium result= 114 mmol/l; repeat result= 141 mmol/l; repeat result (i-stat) = 140 mmol/l.Update, additional patient information was provided on 01jul2025.The patient was a 53-year-old male.There was no impact to patient management reported.
Additional Manufacturer Narrative
Updated information was added to sections a2 - age at time of event, a2 - age units (patient), a3a - sex, b5 - describe event or problem and h4 - device mfg date.The field service representative inspected the architect c4000, serial number (b)(6), performed troubleshooting and observed the tubing, ict pinch valve (rohs) was dirty.The fsr cleaned the tubing, ict pinch valve (rohs) which resolved the issue.Return testing was not completed as returns were not available.The instrument service history for the (b)(6) found an additional complaint received for falsely depressed sodium and potassium results.The tubing, ict pinch valve (rohs) and nozzle c4 #1, #4, #5 (rohs) were replaced to resolve the issue.There was no subsequent complaint issues reported related to false depressed sodium 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) 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.

• 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: 22306866
• Report Number: 3016438761-2025-00354
• Device Sequence Number: 20987885
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/23/2025
• 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: TUBING, ICT PINCH VALVE (ROHS), 7-204068-01, UNKNO
• Patient Age: 53 YR
• Patient Sex: Male