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

Catalog Number 03P68-24

Device Problem High Test Results (2457)

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

Event Date 11/16/2023

Event Type  malfunction  

Event Description

The customer observed a falsely elevated magnesium result for one patient on an architect c4000 analyzer.The following data was provided (customer¿s reference range is 1.6-2.6 mg/dl): sample id 3114757359 initial result was 6.44, repeat was 2.17, repeat, on another analyzer, was 3.5 mg/dl.There was no impact to patient management 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 a falsely elevated magnesium result on an architect c4000 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 the issue appears to be specific to the documented patient sample.As part of the troubleshooting, the same sample was rerun on the same instrument and other instrument with the same reagent lot generated lower results.The technician ran a precision with this sample and results were all close to 2.17 mg/dl, which is the correct result for the patient medical history.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 51199ud00, was identified.

Event Description

The customer observed a falsely elevated magnesium result for one patient on an architect c4000 analyzer.The following data was provided (customer¿s reference range is 1.6-2.6 mg/dl): sample id (b)(6)initial result was 6.44, repeat was 2.17, repeat, on another analyzer, was 3.5 mg/dl.There was no impact to patient management 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18293087
• MDR Text Key: 330063068
• Report Number: 3005094123-2023-00363
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740169855
• UDI-Public: 00380740169855
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2024
• Device Catalogue Number: 03P68-24
• Device Lot Number: 51199UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C4000 INTGR, 02P24-40, (B)(6); ARC C4000 INTGR, 02P24-40, (B)(6)