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	08/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated magnesium on the architect c4000 processing module for two patients.The following results were provided (reference range 1.5 ¿ 2.2 mg/dl): (b)(6) 2025, sid (b)(6) (newborn), initial magnesium result= 5.95 mg/dl; (b)(6) 2025, repeat result= 2.10 mg/dl (b)(6) 2025, sid (b)(6), initial magnesium result= 8.54 mg/dl; repeat result= 1.70 mg/dl there was no impact to patient management reported.
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 on the architect c4000 processing module for two patients.The following results were provided (reference range 1.5 ¿ 2.2 mg/dl): (b)(6) 2025, sid (b)(6) (newborn), initial magnesium result= 5.95 mg/dl; 04aug2025, repeat result= 2.10 mg/dl.(b)(6) 2025, sid (b)(6), initial magnesium result= 8.54 mg/dl; repeat result= 1.70 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from architect magnesium, list number 03p68-24, abbott ireland diagnostics division to architect c4000 processing module, list number 02p24-01, abbott laboratories.Mdr number 3016438761-2025-00505 has been submitted and all further information will be documented under that mdr number.

• 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: 22828004
• Report Number: 3005094123-2025-00399
• Device Sequence Number: 4463605
• Product Code: JGJ
• UDI-Device Identifier: 00380740169855
• UDI-Public: (01)00380740169855(17)251025(10)71414UD00
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 10/25/2025
• Device Catalogue Number: 03P68-24
• Device Lot Number: 71414UD00
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 C4 PROC MOD, 02P24-01, (B)(6).; ARC C4 PROC MOD, 02P24-01, (B)(6).
• Patient Sex: Unknown