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	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated potassium results generated by the architect c4000 processing module for multiple patients.The samples were repeated, and normal lower results were obtained.The customer provided one example: customer¿s normal range: 3.5 to 5.1 mmol/l.Initial potassium result = 7.8 mmol/l, repeat result = 3.0 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The customer provided additional information on 23dec2025.The following sections were updated: section a1 - patient identifier: update from blank to multiple: sample id (b)(6), (55-year-old male), sample id sid (b)(6): section a2 - age at time of event, a2 - age units (patient) , a3a - sex: updated from blank to 55-years-old male.Section b5 - describe event or problem: updated with additional information.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
Update: on (b)(6) 2025, the customer provided two additional patients with falsely elevated potassium results.The following data was provided: sid (b)(6) (55-year-old male): initial potassium result = 8.0 mmol/l, repeat result = 4.2 mmol/l.Sid(b)(6): initial potassium result = 8.9mmol/l, repeat result = 4.49 mmol/l no impact to patient management was reported.
Event or Problem Description
The customer reported falsely elevated potassium results generated by the architect c4000 processing module for multiple patients.The samples were repeated, and normal lower results were obtained.The customer provided one example: customer¿s normal range: 3.5 to 5.1 mmol/l initial potassium result = 7.8 mmol/l, repeat result = 3.0 mmol/l no impact to patient management was reported.Update: on (b)(6) 2025, the customer provided two additional patients with falsely elevated potassium results.The following data was provided: sid (b)(6), (55-year-old male): initial potassium result = 8.0 mmol/l, repeat result = 4.2 mmol/l sid(b)(6): initial potassium result = 8.9mmol/l, repeat result = 4.49 mmol/l no impact to patient management was reported.Update: on (b)(6) 2026, the customer provided one additional patient with falsely elevated potassium result.The following data was provided: sid (b)(6): initial potassium result = 6.9 mmol/l, repeat result = 4.2 mmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
Section a1 - patient identifier: sample ids = (b)(6) (55-year-old male), (b)(6) section b5 - describe event or problem: was updated with additional information.The field service representative (fsr) inspected the instrument and replaced multiple parts when troubleshooting the issue including the tubing (iref pump 12 to iref btl).The fsr determined the tubing (iref pump 12 to iref btl) was cause of false elevated patient results as the part was clogged.A review of instrument service history for serial number (b)(6) revealed that no additional discrepant result issues have been reported since the service activity was completed.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 an increase in complaint activity associated with the complaint issue.Additionally, a review of complaint and trending data associated with the tubing (iref pump 12 to iref btl) did not identify any trends.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 tubing (iref pump 12 to iref btl).

• 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: 23882128
• Report Number: 3016438761-2025-00766
• Device Sequence Number: 11954992
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2026

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: 12/09/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 01/19/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/13/2026; 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2020
• 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, 02P32-11, 35855UN25; CONC ICT DILUENT, 02P32-11, 35855UN25; CONC ICT DILUENT, 02P32-11, 35855UN25
• Patient Age: 55 YR
• Patient Sex: Male