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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier: sample ids = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely decreased results on multiple assays generated by the architect c4000 processing module for multiple patients.The samples were repeated, and normal results were obtained.The following data was provided: customer¿s normal range: sodium: 136 to 145 mmol/l potassium: 3.5 to 5.1 mmol/l calcium: 8.4 to 10.2 mg/dl total bilirubin: 0.2 to 1.2 mg/dl.On (b)(6) 2025, sid (b)(6): initial sodium result = 106 mmol/l, repeat result = 139 mmol/l.On (b)(6) 2025, sid (b)(6): initial potassium result = 2.2 mmol/l, repeat result = 4.1 mmol/l , initial sodium result = 107 mmol/l, repeat result = 138 mmol/l.On (b)(6) 2025, sid (b)(6): initial sodium result = 112 mmol/l, repeat result = 141 mmol/l , initial total bilirubin result = < 0.1 mg/dl, repeat result = 0.4 mg/dl.On (b)(6) 2025, sid (b)(6): initial calcium result = 5.7 mg/dl, repeat result = 9.2 mg/dl.On (b)(6) 2025, sid (b)(6): initial potassium result = 2.2 mmol/l, repeat result = 3.9 mmol/l, initial sodium result = 120 mmol/l, repeat result = 138 mmol/l , no impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and replaced worn vacuum pump, which resolved the issue.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 vacuum pump 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 vacuum pump.
Event or Problem Description
The customer reported falsely decreased results on multiple assays generated by the architect c4000 processing module for multiple patients.The samples were repeated, and normal results were obtained.The following data was provided: customer¿s normal range: sodium: 136 to 145 mmol/l.Potassium: 3.5 to 5.1 mmol/l.Calcium: 8.4 to 10.2 mg/dl.Total bilirubin: 0.2 to 1.2 mg/dl.(b)(6) 2025 sid (b)(6): initial sodium result = 106 mmol/l, repeat result = 139 mmol/l.(b)(6) 2025 sid (b)(6): initial potassium result = 2.2 mmol/l, repeat result = 4.1 mmol/l.Initial sodium result = 107 mmol/l, repeat result = 138 mmol/l.(b)(6) 2025 sid (b)(6): initial sodium result = 112 mmol/l, repeat result = 141 mmol/l.Initial total bilirubin result = < 0.1 mg/dl, repeat result = 0.4 mg/dl.(b)(6) 2025 sid (b)(6): initial calcium result = 5.7 mg/dl, repeat result = 9.2 mg/dl.(b)(6) 2025 sid (b)(6): initial potassium result = 2.2 mmol/l, repeat result = 3.9 mmol/l.Initial sodium result = 120 mmol/l, repeat result = 138 mmol/l.No impact to patient management was 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: 23633924
• Report Number: 3016438761-2025-00685
• Device Sequence Number: 9290261
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 02/09/2026

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: 11/06/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2012
• 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: ARC TBILI2 KIT 900T, 04T09-20, (B)(6).; ARC TBILI2 KIT 900T, 04T09-20, (B)(6).; CC CALCIUM (1500T), 03L79-22, (B)(6).; CC CALCIUM (1500T), 03L79-22, (B)(6).; CONC ICT DILUENT, 02P32-50, (B)(6).; CONC ICT DILUENT, 02P32-50, (B)(6).
• Patient Sex: Unknown