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

Catalog Number 08P19-34

Device Problem High Test Results (2457)

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

Event Date 03/14/2024

Event Type  malfunction  

Event Description

The customer observed falsely elevated magnesium results on alinity c processing module for several patients.The results provided were: on (b)(6) 2024 sid (b)(6) initial=7.3 mg/dl /repeated=1.48 mg/dl /repeated on both alinity module=1.67 and 1.54 mg/dl there was no reported impact to patient management.

Manufacturer Narrative

Complete information for section a patient information, 1.Patient identifier = sid= (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history records for alinity c magnesium reagent, lot number 57143ud00.The ticket search determined that there is as expected complaint activity for the likely cause lot.Trending review determined no trend for the issue for the product.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the alinity c magnesium reagent, lot number 57143ud00 was identified.

Event Description

The customer observed falsely elevated magnesium results on alinity c processing module for one patient.The results provided were: on (b)(6) 2024 sid (b)(6) initial=7.3 mg/dl /repeated=1.48 mg/dl /repeated on both alinity module=1.67 and 1.54 mg/dl there was no reported impact to patient management.

• 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: 18949007
• MDR Text Key: 338431649
• Report Number: 3005094123-2024-00136
• Device Sequence Number: 1
• Product Code: JGJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 05/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08P19-34
• Device Lot Number: 57143UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC01811; ALNTY C PROCESSING MODU, 03R67-01, AC01811