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	02/25/2026
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.
Event or Problem Description
The customer observed falsely elevated magnesium results generated on the architect c4000 instrument for a 25-year-old female patient.The following data was provided (normal range 1.6 - 2.6 mg/dl): sid (b)(6) (b)(6) 2026 resulted 8.0 repeated 1.8, 1.9 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the architect c4000, serial number (b)(6) to address the customer¿s observation of falsely elevated results.The customer inspected the instrument and determined the cc cuv dry tip the cause of the result issue.To resolve the issue the part was replaced, and the issue was resolved.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.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 tracking and trending did not identify any trends regarding the customer reported event.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and adequately addressed the issue under review.Based on the investigation, no systemic issue or deficiency was identified.
Event or Problem Description
The customer observed falsely elevated magnesium results generated on the architect c4000 instrument for a 25-year-old female patient.The following data was provided (normal range 1.6 - 2.6 mg/dl): sid (b)(6) 2026 resulted 8.0 repeated 1.8, 1.9 mg/dl.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: 24637410
• Report Number: 3016438761-2026-00144
• Device Sequence Number: 15899303
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/31/2026

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: 02/28/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2018
• 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: CC MAGNESIUM (1000T), 03P68-24, 77641UD00.; CC MAGNESIUM (1000T), 03P68-24, 77641UD00.
• Patient Age: 25 YR
• Patient Sex: Female