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	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete entry for section a1 - patient identifier: (b)(6).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 results generated on the architect c4000 instrument.The following results were provided: sid: (b)(6).Gender: male age: 83 initial result 6.31 mg/dl, repeated 2.06 / 2.03 / 2.22 mg/dl.(customer ref range ref range 1.8 -2.4 mg/dl).No impact to patient management was reported.
Additional Manufacturer Narrative
The data and information provided by the customer were reviewed and support the complaint issue.The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review ticket search by lot indicates that the reagent lot performs as expected for this product.Ticket trending review for the list number did not identify any related trends.A review in the corrective and preventive actions (capa) system did not identify any nonconformances, potential nonconformance or deviations associated with the complaint assay.The overall performance of the architect magnesium assays in the field was reviewed using data gathered from customers worldwide.The patient median data were analyzed and compared to an established control limit.This evaluation indicated that the patient median result for the lot numbers in the field for lot number 73190ud00 is within the established control limits, indicating that the lot is performing acceptably in the field.Labeling was reviewed and was found to address the customer reported issue.Based on this investigation, no systemic issue or deficiency was identified with the architect magnesium assay, lot number 73190ud00.
Event or Problem Description
The customer observed falsely elevated magnesium results generated on the architect c4000 instrument.The following results were provided: sid:(b)(6).Gender: male age: 83.Initial result 6.31 mg/dl, repeated 2.06 / 2.03 / 2.22 mg/dl.(customer ref range ref range 1.8 -2.4 mg/dl).No impact to patient management was reported.

• 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: 23464435
• Report Number: 3005094123-2025-00554
• Device Sequence Number: 18743799
• Product Code: JGJ
• UDI-Device Identifier: 00380740169855
• UDI-Public: (01)00380740169855(17)251215(10)73190UD00
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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 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: 10/15/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 01/15/2026
• 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); ARC C4000 INTGR, 02P24-40, (B)(6)
• Patient Age: 83 YR
• Patient Sex: Male