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.

• 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
• UDI-Device Identifier: 00380740176532
• UDI-Public: 00380740176532
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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, (B)(6)