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	11/21/2025
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.All available patient information was included.Additional patient details were not provided.
Event or Problem Description
The customer reported a falsely elevated magnesium result generated on an architect c4000 analyzer for one patient.Sid (b)(6) initial result = 5.98 mg/dl, repeat results = 1.98 mg/dl and 1.90 mg/dl (normal range 1.6-2.5 mg/dl).There was no impact to patient management.
Event or Problem Description
The customer reported a falsely elevated magnesium result generated on an architect c4000 analyzer for one patient.Sid (b)(6) initial result = 5.98 mg/dl, repeat results = 1.98 mg/dl and 1.90 mg/dl (normal range 1.6-2.5 mg/dl).There was no impact to patient management.
Additional Manufacturer Narrative
Abbott service inspected the instrument and replaced the cuvette dry tip, which resolved the issue.Issue resolution was verified with a passing precision run.No additional discrepant results were reported since the part was replaced.The instrument service history review revealed no additional tickets associated with discrepant/erratic patient results.A review of trending data associated with the cuvette dry tip did not identify a trend.A review of complaint and trending data for the architect c4000 system did not identify any similar issues as described in the complaint.Review of manufacturing documentation did not identify any potential non-conformances or nonconformances for the cuvette dry tip.Labeling was reviewed and adequately addresses the complaint issue.Based on the investigation, no systemic issue or deficiency was identified for the architect c4000, (b)(6).

• 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: 23757271
• Report Number: 3016438761-2025-00707
• Device Sequence Number: 10150324
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: 02P24-40
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 12/27/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2020
• 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: CC MAGNESIUM (1000T), 03P68-24,; CC MAGNESIUM (1000T), 03P68-24,
• Patient Sex: Unknown