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

Model Number 03P6824

Device Problem High Test Results (2457)

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

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.

Event Description

The customer reported a falsely elevated magnesium result generated on the architect c8000 analyzer on a patient.Results provided: 3.8 / 1.3 mg/dl (reference range: 1.6 - 2.6 md/dl).No impact to patient management was provided.

Manufacturer Narrative

A review of complaints determined that there are no trends for the product for the complaint issue.A lot search was not performed as the likely cause lot is unknown.Return testing was not completed as returns were not available.Historical performance in the field of reagent lots using world-wide data through abbottlink was evaluated and shows that the within date lots are performing as expected.A review of the manufacturing documentation for the likely cause did not identify any issues associated with the customer¿s observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no product deficiency was identified.

Event Description

The customer reported a falsely elevated magnesium result generated on the architect c8000 analyzer on a patient.Results provided: 3.8 / 1.3 mg/dl (reference range: 1.6 - 2.6 md/dl).No impact to patient management was provided.

• 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: 16655420
• MDR Text Key: 312733359
• Report Number: 3005094123-2023-00081
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03P6824
• Device Catalogue Number: 03P68-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C8 PROC MOD, 01G06-11, C804157; ARC C8 PROC MOD, 01G06-11, C804157