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

Model Number 08P1934

Device Problem High Test Results (2457)

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

Event Date 04/15/2023

Event Type  malfunction  

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.

Event Description

The customer observed falsely elevated magnesium results for one patient on an alinity c analyzer.The following data was provided (customer¿s normal range is 0.7-1.10 mmol/l): sample id (b)(6) initial result, on 15apr, was 2.48, repeat was 0.83 mmol/l.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for falsely elevated alinity c magnesium results 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.The historical performance of reagent lot 47345ud00 was evaluated using worldwide data from abbottlink.Patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 47345ud00 is inside the established control limits, which indicates acceptable product performance.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 alinity c magnesium, lot number 47345ud00, was identified.

Event Description

The customer observed falsely elevated magnesium results for one patient on an alinity c analyzer.The following data was provided (customer¿s normal range is 0.7-1.10 mmol/l): sample id (b)(6) initial result, on 15apr, was 2.48, repeat was 0.83 mmol/l.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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16863506
• MDR Text Key: 314546769
• Report Number: 3005094123-2023-00119
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: 00380740176532
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181748
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2023
• Device Model Number: 08P1934
• Device Catalogue Number: 08P19-34
• Device Lot Number: 47345UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC02158; ALNTY C PROCESSING MODU, 03R67-01, AC02158