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	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This follow-up submission sends for additional information received on 05may2025, the likely cause product has been changed from the architect c4000 analyzer, list number 02p24-40 to the cc magnesium reagent list number 03p68-24.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 falsely elevated magnesium on the architect c4000 processing module for a male patient.Results were not reported to the medical provider.The following results were provided (reference range 1.8-2.6 mg/dl): initial result =7.1 mg/dl, repeat results = 1.8, 5.93, 1.73 and 1.76 mg/dl.There was no impact to patient management reported.
Event or Problem Description
The customer observed falsely elevated magnesium on the architect c4000 processing module for a male patient.Results were not reported to the medical provider.The following results were provided (reference range 1.8-2.6 mg/dl): initial result =7.1 mg/dl, repeat results = 1.8, 5.93, 1.73 and 1.76 mg/dl.There was no impact to patient management reported.
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.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.Review of tracking and trending for the magnesium reagent lot did not identify an increase in complaint activity related to the complaint issue.Device history review did not identify any non-conformances or deviations with the complaint lot.No testing performed on a file sample was performed as the issue appears to be isolated to specific samples/ reagent cartridge.Sample was repeated with new reagent cartridge and rerun generated an acceptable result.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the magnesium reagent lot 66313ud00 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: 22019764
• Report Number: 3005094123-2025-00238
• Device Sequence Number: 12962935
• Product Code: JGJ
• UDI-Device Identifier: 00380740169855
• UDI-Public: (01)00380740169855(17)250508(10)66313UD00
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: 05/08/2025
• Device Catalogue Number: 03P68-24
• Device Lot Number: 66313UD00
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• 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); ARC C4000 INTGR, 02P24-40, (B)(6)
• Patient Sex: Male