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

Catalog Number	03P68-34
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
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 observed a falsely elevated magnesium result for one patient on an architect c16000.The following data was provided (customer¿s reference range is 1.6-2.6 mg/dl): sample id (b)(6) initial result was 8.2, repeat was 2.1 mg/dl.The sample was repeated five times for a precision study and the results were all 2.1 mg/dl.There was no impact to patient management reported.
Event or Problem Description
The customer observed a falsely elevated magnesium result for one patient on an architect c16000.The following data was provided (customer¿s reference range is 1.6-2.6 mg/dl): sample id (b)(6) initial result was 8.2, repeat was 2.1 mg/dl.The sample was repeated five times for a precision study and the results were all 2.1 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for a falsely elevated magnesium result on an architect c16000 analyzer included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Trending review determined no related trend for the issue for the product.File sample analysis was not performed as part of the troubleshooting, the same sample was rerun on the same analyzer with the same reagent lot, which generated lower results.The technician ran a precision with this sample and results were all 2.1 mg/dl.The quality control was performing within the expected ranges, which shows that the assay was performing as expected.No additional issues were identified.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of the magnesium reagent, lot number 58361ud00, was identified.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19373172
• Report Number: 3005094123-2024-00275
• Device Sequence Number: 7466277
• Product Code: JGJ
• UDI-Device Identifier: 00380740169862
• UDI-Public: (01)00380740169862(17)241004(10)58361UD00
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 07/02/2024

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: 10/04/2024
• Device Catalogue Number: 03P68-34
• Device Lot Number: 58361UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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: ARC C16K PRC MOD, 03L77-01, C1601629; ARC C16K PRC MOD, 03L77-01, C1601629
• Patient Sex: Unknown