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

Catalog Number	08P19-34
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported falsely elevated alinity c magnesium result for an 80-year-old male patient.The following data was provided (customer provided reference range: 1.6 to 2.3 mg/dl): on (b)(6) 2025, sid (b)(6): initial result = 8.3 mg/dl, repeat on another alinity = 2.0 mg/dl the discrepant result was not reported out of the laboratory.No impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from the alinity c magnesium, 08p19-34, abbott ireland diagnostics division to alinity c processing module, 03r67-01, abbott laboratories.Mdr number 3016438761-2025-00739 has been submitted and all further information will be documented under that mdr number.
Event or Problem Description
The customer reported falsely elevated alinity c magnesium result for an 80 year old male patient.The following data was provided (customer provided reference range: 1.6 to 2.3 mg/dl): 11nov2025, sid (b)(6): initial result = 8.3 mg/dl, repeat on another alinity = 2.0 mg/dl the discrepant result was not reported out of the laboratory.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: 23567619
• Report Number: 3005094123-2025-00575
• Device Sequence Number: 13233077
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: (01)00380740176532(17)260123(10)74272UD01
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/18/2025

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 Catalogue Number: 08P19-34
• Device Lot Number: 74272UD01
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 80 YR
• Patient Sex: Male