MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Catalog Number	03P68-24
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated magnesium result generated on an architect c4000 analyzer for one patient.Sid (b)(6) initial result = 0.77 mmol/l, repeat results = 0.53 mmol/l.The previous result from the day prior was 0.51 mmol/l.The customer¿s normal reference range is 0.7-1.1 mmol/l.There was no impact to patient management.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Review of tracking and trending for the magnesium assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 73190ud00.Device history record review did not identify any non-conformances related to the complaint lot number.Labeling was reviewed and found to adequately address the issue under review.Based on the information, no systemic issue or deficiency with the magnesium reagent lot 73190ud00 was identified.

• Brand Name: ARCHITECT MAGNESIUM
• Common Device Name: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 22979542
• Report Number: 3005094123-2025-00430
• Device Sequence Number: 15810032
• Product Code: JGJ
• UDI-Device Identifier: 00380740169855
• UDI-Public: (01)00380740169855(17)251215(10)73190UD00
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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 Expiration Date: 12/15/2025
• Device Catalogue Number: 03P68-24
• Device Lot Number: 73190UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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 C4000 INTGR, 02P24-40, (B)(6)
• Patient Sex: Unknown