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

Model Number	03P6824
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated magnesium results generated on the architect c8000 processing module for one sample.Results provided: (customer provided reference range: 0.7 - 2.0 mg/dl).(b)(6) 2023 initial result = > 9.5 mg/dl, repeat result = 8.8 mg/dl, sample repeated a third time = 2.0 mg/dl.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.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated magnesium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.The device history record review did not identify any non-conformances or deviations with lot number 46427ud00 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Customer field data was used to assess the performance of the magnesium assay using worldwide data.Review shows that the median patient result for lot 46427ud00 is within established limits and comparable with other lots in the field, confirming no systemic issue for lot 46427ud00.Based on the investigation, no systemic issue or deficiency with the magnesium assay for lot 46427ud00 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated magnesium results generated on the architect c8000 processing module for one sample.Results provided: (customer provided reference range: 0.7 - 2.0 mg/dl).24apr2023 initial result = > 9.5 mg/dl, repeat result = 8.8 mg/dl, sample repeated a third time = 2.0 mg/dl.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: 16975024
• Report Number: 3005094123-2023-00132
• Device Sequence Number: 2453163
• Product Code: JGJ
• UDI-Device Identifier: 00380740169855
• UDI-Public: 00380740169855
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 07/07/2023

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: 09/29/2023
• Device Model Number: 03P6824
• Device Catalogue Number: 03P68-24
• Device Lot Number: 46427UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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 C8 PROC MOD, 01G06-11, C804613; ARC C8 PROC MOD, 01G06-11, C804613
• Patient Sex: Unknown