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	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint investigation was conducted for the alinity c magnesium lot 77635ud00 to address the customer¿s observation of falsely elevated results.As part of troubleshooting the customer rerun the samples and obtained acceptable results.The quality control results were also acceptable at the time of testing.The customer thinks this is due to reagent bubbles.Review of tracking and trending by list number and by complaint lot did not identify any trends.Labeling was reviewed and found to adequately address the issue under review.Based on our investigation, no systemic issue or deficiency was identified with the alinity c magnesium lot 77635ud00.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer observed falsely elevated alinity c magnesium results for two patients.The following data was provided: sid (b)(6), initial result on (b)(6) 2026 at 1720 >9.5 mg/dl (reported out of the lab), repeated 1.92 mg/dl (normal range 1.4 to 2.4 mg/dl).A new sample was obtained sid (b)(6) resulted (b)(6) 2026 at 1853 result 1.91 mg/dl.No sid provided, initial result >9.5 mg/dl, repeated 1.67 mg/dl.No impact to patient management was reported.

• 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: 24927425
• Report Number: 3005094123-2026-00187
• Device Sequence Number: 5179779
• Product Code: JGJ
• UDI-Device Identifier: 00380740176525
• UDI-Public: (01)00380740176525(17)260502(10)77635UD00
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 05/06/2026

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: 04/16/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/06/2026
• 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
• Patient Sex: Unknown