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

Model Number 03P6824

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated magnesium results generated on the architect c4000 for multiple patient samples.The following data was provided (customer¿s reference range 0.7-1.1 mmol/l): (b)(6) 2023 sample id 681167149 initial = 3.543 mmol/l, repeat = 1.504 mmol/l, 0.808 mmol/l, 0.815 mmol/l, 77% no impact to patient management was reported.

Manufacturer Narrative

Additional information d4 - expiration date and h4 - device mfg date.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.A review of tracking and trending did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with the complaint lot.The overall performance of architect magnesium reagents was reviewed 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 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 46424ud00.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the architect magnesium reagent kit, lot number 46424ud00, was identified.

Event Description

The customer observed falsely elevated magnesium results generated on the architect c4000 for multiple patient samples.The following data was provided (customer¿s reference range 0.7-1.1 mmol/l): 10may2023 sample id (b)(6) initial = 3.543 mmol/l, repeat = 1.504 mmol/l, 0.808 mmol/l, 0.815 mmol/l, 77%.No impact to patient management was reported.

• Brand Name: MAGNESIUM
• Type of Device: 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: 17051016
• MDR Text Key: 316596305
• Report Number: 3005094123-2023-00141
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2023
• Device Model Number: 03P6824
• Device Catalogue Number: 03P68-24
• Device Lot Number: 46424UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4 PROC MOD, 02P24-01, C461905; ARC C4 PROC MOD, 02P24-01, C461905