MAUDE Adverse Event Report: A.I.D.D LONGFORD MAGNESIUM; PHOTOMETRIC METHOD, MAGNESIUM

Model Number 03P6834

Device Problem High Test Results (2457)

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

Event Date 11/26/2022

Event Type  malfunction  

Event Description

The customer observed falsely elevated magnesium results generated on the architect c4000 processing module for multiple samples.The following example results were provided: on (b)(6) 2022.Initial result = 7.9mgdl, repeat result on another analyzer= 1.3mg/dl.On (b)(6) 2022.Initial result = 6mg/dl, repeat result on another analyzer= 2.1mg/dl reference (normal) range: 1.6 to 2.6 mg/dl.No impact to patient management was reported.

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.

Manufacturer Narrative

The complaint investigation for false elevated architect 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 complaint issue.Labeling was reviewed and found to adequately address the issue.Data from customers worldwide was used to assess the performance of the architect magnesium assay.The median patient result for lot 39508ud00 is within established limits and comparable with other lots in the field, which indicates acceptable product performance.Device history record review on lot 39508ud00 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Based on the investigation, no systemic issue or deficiency of the architect magnesium assay for lot number 39508ud00 was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: MAGNESIUM
• Type of Device: PHOTOMETRIC METHOD, MAGNESIUM
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; 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: 16059207
• MDR Text Key: 307224731
• Report Number: 3005094123-2022-00309
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740169862
• UDI-Public: 00380740169862
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: 03P6834
• Device Catalogue Number: 03P68-34
• Device Lot Number: 39508UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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, (B)(4).; ARC C4 PROC MOD, 02P24-01, (B)(4).