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	10/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated alinity c magnesium (mg) results generated for a 4-year-old patient sample.The following data was provided (customer¿s reference range: 5 months to 6 years old 0.70 - 0.95 mmol/l): on (b)(6) 2025, sample id (b)(6), initial result = 2.98 mmol/l, repeat result = 0.7 mmol/l, (b)(6) 2025.Same patient, new sample obtained.Sample id (b)(6) results = 2.5 mmol/l, 0.3 mmol/l.No impact to patient management was reported.
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).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 alinity c magnesium (mg) results generated for a 4-year-old patient sample.The following data was provided (customer¿s reference range: 5 months to 6 years old 0.70 - 0.95 mmol/l): (b)(6) 2025 sample id (b)(6).Initial result = 2.98 mmol/l, repeat result = 0.7 mmol/l, 27oct2025 same patient, new sample obtained.Sample id (b)(6) results = 2.5 mmol/l, 0.3 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot did not identify an increase in complaint activity.A review of tracking and trending for the alinity c magnesium assay did not identify any related trends.Device history record review did not identify any related nonconformance, potential nonconformance or deviations associated with lot number 77635ud00 and complaint issue.The historical performance of reagent lot 77635ud00 was evaluated using world-wide data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 77635ud00 is within the established control limits.Therefore, no unusual reagent lot performance was identified.In this case, the customer reran the sample with the same reagent lot and generated acceptable results.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 assay, lot 77635ud00 was identified.

• 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: 23497072
• Report Number: 3005094123-2025-00564
• Device Sequence Number: 9115434
• Product Code: JGJ
• UDI-Device Identifier: 00380740176525
• UDI-Public: (01)00380740176525(17)260502(10)77635UD00
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/21/2026

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: 10/28/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/21/2026
• 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 PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Age: 4 YR
• Patient Sex: Unknown