MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C8000 PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01G06-11
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
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 are not available.
Event or Problem Description
The customer reported a falsely elevated magnesium result generated on the architect c8000 processing module for one patient.The following data was provided (customer¿s reference range: 0.7-0.91 mmol/l): initial magnesium result = 3.5 mmol/l repeat magnesium result = 0.76 mmol/l no incorrect results were released.No impact to patient management was reported.
Event or Problem Description
The customer reported a falsely elevated magnesium result generated on the architect c8000 processing module for one patient.The following data was provided (customer¿s reference range: 0.7-0.91 mmol/l): initial magnesium result = 3.5 mmol/l repeat magnesium result = 0.76 mmol/l no incorrect results were released.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative inspected the architect c8000 processing module, serial number (b)(6), and performed multiple troubleshooting procedures including replacement of the mixer (09d59-04).Replacing the part resolved the issue.The instrument service history review revealed no additional ticket associated with discrepant/erratic magnesium patient results.There were no additional 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 alinity i processing module did not identify any similar issues related to the architect system, parts, or discrepant results as described in this complaint.Additionally review of complaint and trending data associated with the mixer (09d59-04) did not identify an increase in complaint activity.The manufacturing documentation was reviewed and did not identify any nonconformances or deviations for the mixer associated with the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the architect c8000 processing module, for serial (b)(6), or the mixer were identified.

• Brand Name: ARCHITECT C8000 PROCESSING MODULE
• 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: 22669080
• Report Number: 3016438761-2025-00443
• Device Sequence Number: 3892655
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: (01)00380740000509
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: 01G06-11
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2007
• 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 (3750T), 03P68-34, 73187UD00; CC MAGNESIUM (3750T), 03P68-34, 73187UD00
• Patient Sex: Unknown