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

Catalog Number	08P19-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 - patient identifier: sids (b)(6) (refer to section b5 for complete patient information).All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 08p19, that has a similar product distributed in the us with the same list number, and a 510k/pma/bla number of k181748.
Event or Problem Description
The customer observed falsely elevated magnesium results for multiple patients when processed on the alinity c processing modules.Results were not reported to medical provider.The following data was provided.On (b)(6) 2026, 37 years female: sid: (b)(6) ; initial result= 7.6 mg/dl, repeat result = 2.1 mg/dl.(b)(6).On (b)(6) 2026, 66 years male: sid: (b)(6) initial result (b)(6) = 7.5 mg/dl, repeat result = 1.9 mg/dl.(b)(6).On (b)(6) 2026, sid (b)(6), initial result =8.1 mg/dl and repeat result =1.8 mg/dl.The customer use reference range: 1.6-2.6 mg/dl.There was no reported impact to patient management.
Additional Manufacturer Narrative
This follow-up submission being send to cross reference mdr: 3005094123-2026-00077-01 for likely cause changed on 02mar2026 from alinity c magnesium reagent, list: 08p19-25 to alinity c processing module, list number: 03r67-01.All further information will be submitted under mdr: 3016438761-2026-00132-00.
Event or Problem Description
The customer observed falsely elevated magnesium results for multiple patients when processed on the alinity c processing modules.Results were not reported to medical provider.The following data was provided.On (b)(6) 2026, 37 years female: sid: (b)(6); initial result= 7.6 mg/dl, repeat result = 2.1 mg/dl.(b)(6).On (b)(6) 2026, 66 years male: sid: (b)(6); initial result (b)(6) = 7.5 mg/dl, repeat result = 1.9 mg/dl.(b)(6).On (b)(6) 2026, sid: (b)(6), initial result =8.1 mg/dl and repeat result =1.8 mg/dl.The customer use reference range: 1.6-2.6 mg/dl.There was no reported impact to patient management.

• Brand Name: ALINITY C 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: 24349575
• Report Number: 3005094123-2026-00077
• Device Sequence Number: 10117819
• Product Code: JGJ
• UDI-Device Identifier: 00380740176525
• UDI-Public: (01)00380740176525(17)260502(10)77635UD00
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 04/28/2026

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: 05/02/2026
• Device Catalogue Number: 08P19-25
• Device Lot Number: 77635UD00
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 04/24/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/12/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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: ALNTY C MAG (720T), 08P19-25, 77635UD00.; ALNTY C MAG (720T), 08P19-25, 77635UD00.
• Patient Sex: Unknown