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	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated magnesium generated from alinity c processing module (sn: (b)(6) that reportedly normalized upon repeat and provided the following: customer normal range is 1.6 to 2.6 mg/dl on (b)(6) 2025, sample id (b)(6): initially was 7.11 and when repeated on the same analyzer, the result was 2.52.Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information has been included.No additional patient details are available.
Additional Manufacturer Narrative
The customer observed a falsely elevated alinity c magnesium result while using reagent lot 74013ud00.As part of troubleshooting the customer rerun the sample using the same reagent lot which generated expected results.Quality controls were within range at the time of the incident.A ticket search by lot 74013ud00 did not identify an increase in complaint activity.A review of tracking and trending for the alinity c magnesium assay did not identify any trends.Device history record review did not identify any nonconformances or deviations associated with the complaint lot and complaint issue.Customer field data was used to assess the performance of the alinity c magnesium assay using worldwide data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 74013ud00 is within the established control limits.Therefore, no unusual reagent lot performance was identified.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity c magnesium, lot 74013ud00 was identified.
Event or Problem Description
The customer observed falsely elevated magnesium generated from alinity c processing module (sn: (b)(6)) that reportedly normalized upon repeat and provided the following: customer normal range is 1.6 to 2.6 mg/dl.On (b)(6) 2025, sample id (b)(6): initially was 7.11 and when repeated on the same analyzer, the result was 2.52.Per the customer the discrepant results were not reported out to the patient¿s medical provider.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: 23815656
• Report Number: 3005094123-2025-00645
• Device Sequence Number: 10006887
• Product Code: JGJ
• UDI-Device Identifier: 00380740176525
• UDI-Public: (01)00380740176525(17)251215(10)74013UD00
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/02/2026

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: 08P19-25
• Device Lot Number: 74013UD00
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• 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 PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6).
• Patient Sex: Unknown