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	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated magnesium results generated by the alinity c processing modules for multiple patients.Upon repeat testing, lower results were obtained.The following data was provided: sid (b)(6) magnesium initial result = 3.90 mg/dl (b)(6), repeat result = 0.79 mg/dl (b)(6).Sid (b)(6) magnesium initial result = 3.90 mg/dl (b)(6), repeat result = 1.03 mg/dl (b)(6).Sid (b)(6) magnesium initial result = 2.57 mg/dl (b)(6), repeat result = 0.83 mg/dl, 0.83 mg/dl (b)(6).Sid (b)(6) magnesium initial result = 1.80 mg/dl (b)(6), repeat result = 0.84 mg/dl, 0.85 mg/dl (b)(6).Sid (b)(6) magnesium initial result = 2.05 mg/dl, repeat result = 0.82 mg/dl.Sid (b)(6) magnesium initial result = 1.71 mg/dl (b)(6), repeat result = 0.79 mg/dl (b)(6).Sid (b)(6) magnesium initial result = 1.93 mg/dl(b)(6), repeat result = 0.95 mg/dl (b)(6).Sid (b)(6) magnesium initial result = 1.65 mg/dl (b)(6), repeat result = 0.87 mg/dl (b)(6).The customer did not provide magnesium reference ranges, the approximate reference (normal) range for magnesium is 1.6 to 2.6 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
Section a1 - patient identifier: sample ids = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
A ticket search by lot 76437ud00 did not identify an increase in complaint activity related to the issue under review.A review of tracking and trending did not identify any trends for the alinity c magnesium assay.Device history review did not identify any nonconformances or deviations associated with the complaint lot number and complaint issue.The historical performance of reagent lot number 76437ud00 was evaluated using data gathered from customers worldwide.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for the lot numbers in the field for lot number 76437ud00 is within the established control limits.Therefore, no unusual reagent performance was identified.Review of product labeling found adequate information regarding the issue under review.In this case, repeat testing using the same reagent lot produced acceptable results and it was confirmed that the quality controls were within the expected ranges.Possible preanalytical problem with cell fragments on the sample surface, which can lead to interference during the first pipetting was suspected.Based on the investigation, no systemic issue or deficiency of the alinity c magnesium assay, lot 76437ud00 was identified.
Event or Problem Description
The customer reported falsely elevated magnesium results generated by the alinity c processing modules for multiple patients.Upon repeat testing, lower results were obtained.The following data was provided: sid (b)(6), magnesium initial result = 3.90 mg/dl (b)(6), repeat result = 0.79 mg/dl (b)(6), sid (b)(6), magnesium initial result = 3.90 mg/dl (b)(6), repeat result = 1.03 mg/dl (b)(6), sid (b)(6), magnesium initial result = 2.57 mg/dl (b)(6), repeat result = 0.83 mg/dl, 0.83 mg/dl (b)(6), sid (b)(6), magnesium initial result = 1.80 mg/dl (b)(6), repeat result = 0.84 mg/dl, 0.85 mg/dl (b)(6), sid (b)(6) ,magnesium initial result = 2.05 mg/dl, repeat result = 0.82 mg/dl, sid (b)(6), magnesium initial result = 1.71 mg/dl (b)(6), repeat result = 0.79 mg/dl (b)(6) , sid (b)(6), magnesium initial result = 1.93 mg/dl (b)(6), repeat result = 0.95 mg/dl (b)(6), sid (b)(6), magnesium initial result = 1.65 mg/dl (b)(6), repeat result = 0.87 mg/dl (b)(6).The customer did not provide magnesium reference ranges, the approximate reference (normal) range for magnesium is 1.6 to 2.6 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: 23198299
• Report Number: 3005094123-2025-00494
• Device Sequence Number: 9730174
• Product Code: JGJ
• UDI-Device Identifier: 00380740176525
• UDI-Public: (01)00380740176525(17)260312(10)76437UD00
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 11/14/2025

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: 03/12/2026
• Device Catalogue Number: 08P19-25
• Device Lot Number: 76437UD00
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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); ALNTY C PROCESSING MODU,03R67-01, (B)(6); ALNTY C PROCESSING MODU,03R67-01, (B)(6); ALNTY C PROCESSING MODU,03R67-01, (B)(6); ALNTY C PROCESSING MODU,03R67-01, (B)(6).
• Patient Sex: Unknown