MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION 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	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely elevated magnesium result generated on the alinity c processing module on a patient.The following results were provided: sid (b)(6) = 2.54 / 0.86 / 0.85 mmol/l (normal range: 0.7-1.0 mmol/l).No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for alinity c magnesium reagent lot number 52268ud00.Trending review determined no trends for discrepant patient results for the product.Worldwide data from abbottlink was reviewed and determined that the patient median result for the magnesium reagent lot number 52268ud00 is within established control limits.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the alinity c magnesium reagent lot number 52268ud00 was identified.
Event or Problem Description
The customer reported a falsely elevated magnesium result generated on the alinity c processing module on a patient.The following results were provided: sid (b)(6) = 2.54 / 0.86 / 0.85 mmol/l (normal range: 0.7-1.0 mmol/l).No impact to patient management was reported.

• Brand Name: 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17649232
• Report Number: 3005094123-2023-00231
• Device Sequence Number: 20636220
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: 00380740176532
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/12/2023

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: 02/16/2024
• Device Catalogue Number: 08P19-34
• Device Lot Number: 52268UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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