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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
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.Section a patient information: refer to section b5 for complete patient information.This report is being filed on an international product, list number 2p24 that has a similar product distributed in the us, list number 2p24-01 / 40, 1r24-98, 1r25-98 with 510k exempt.
Event or Problem Description
The customer observed falsely elevated potassium on the architect c4000 processing module for two patients.The samples were repeated with lower results.The following results were provided: sid (b)(6), initial potassium result= 7.923 mmol/l; repeat result= 4.767 mmol/l sid (b)(6), initial potassium result= 7.977 mmol/l; repeat result= 4.561 mmol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument, and the ict module was determined to be the cause of the result issue.A review of instrument service history for serial number (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 c4000 processing module did not identify any similar issues as described in this complaint.Additionally, a review of complaint and trending data associated with the ict module did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency was identified for the architect c4000 processing module, serial number (b)(6), or the ict module.
Event or Problem Description
The customer observed falsely elevated potassium on the architect c4000 processing module for two patients.The samples were repeated with lower results.The following results were provided: sid (b)(6), initial potassium result= 7.923 mmol/l; repeat result= 4.767 mmol/l.Sid (b)(6), initial potassium result= 7.977 mmol/l; repeat result= 4.561 mmol/l.There was no impact to patient management reported.

• 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: 24547531
• Report Number: 3016438761-2026-00124
• Device Sequence Number: 13132983
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/06/2026

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: 02/18/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2016
• 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: CONC ICT DILUENT, 02P32-50, (B)(6); CONC ICT DILUENT, 02P32-50, (B)(6); ICT MODLE, 09D28-04, (B)(6); ICT MODLE, 09D28-04, (B)(6)
• Patient Sex: Unknown