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

Model Number 03P6834

Device Problem High Test Results (2457)

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

Event Date 07/05/2023

Event Type  malfunction  

Event Description

The customer observed a falsely elevated magnesium results generated on the architect c16000 processing module for one sample.The following data was provided: sid (b)(6) initial result = 3.165 mmol/l, repeat = 0.924 mmol/l.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.

Event Description

The customer observed a falsely elevated magnesium results generated on the architect c16000 processing module for one sample.The following data was provided: (b)(6) initial result = 3.165 mmol/l, repeat = 0.924 mmol/l no impact to patient management was reported.

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.Device history record review did not identify any non-conformances or deviations with lot 46424ud00 and the complaint issue.The overall performance of magnesium was reviewed using field data from customers worldwide.The patient data was analyzed and shows the patient median is within the established limits.Therefore, no unusual reagent lot performance was identified for lot 46424ud00.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the magnesium reagent for lot 46424ud00 was identified.

• 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: 17373628
• MDR Text Key: 319832221
• Report Number: 3005094123-2023-00183
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740169862
• UDI-Public: 00380740169862
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• 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: 03P6834
• Device Catalogue Number: 03P68-34
• Device Lot Number: 46424UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• 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 C16K PRC MOD, 03L77-01, (B)(6).; ARC C16K PRC MOD, 03L77-01, (B)(6).