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	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated magnesium on the architect c4000 processing module for a 79-year-old male.The following results were provided (reference range 1.6 - 2.6 mg/dl): sid (b)(6), initial magnesium result= 6.6 mg/dl; repeat result= 2.1 mg/dl.There was no impact to patient management reported.
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 are not available.
Event or Problem Description
The customer observed a falsely elevated magnesium on the architect c4000 processing module for a 79-year-old male.The following results were provided (reference range 1.6 - 2.6 mg/dl): sid (b)(6), initial magnesium result= 6.6 mg/dl; repeat result= 2.1 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the architect c4000 processing module, serial number (b)(6) to address the customer¿s observation of falsely elevated magnesium results.The customer inspected the module and performed multiple troubleshooting procedures including part replacement, calibration and quarterly maintenance without resolution.The field service representative (fsr) inspected the module and determined the cuvette washer, c4 (rohs) was the cause of the issues and replaced the part.Part replacement resolved the issue.No additional discrepant result issues have been reported.The instrument service history review revealed no additional tickets associated with discrepant/erratic patient results.A review of tracking and trending did not identify any trends with regards to 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.Based on our investigation, no systemic issue or deficiency was identified.

• 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: 23960246
• Report Number: 3016438761-2026-00006
• Device Sequence Number: 9610927
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 02/26/2026

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: 12/17/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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, 75415UD00; CC MAGNESIUM (1000T), 03P68-24, 75415UD00
• Patient Age: 79 YR
• Patient Sex: Male