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

Model Number 08P1934

Device Problem Low Test Results (2458)

Patient Problem Insufficient Information (4580)

Event Date 02/10/2023

Event Type  Injury  

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 decreased magnesium results which questioned by the physician on alinity c processing module for several patients.The customer stated 8 patients given medial treatment 2g magnesium in 50ml saline intravenously based on initial magnesium results.The quality controls out of ranges before generating the discrepant magnesium results.There were no actual results provided by the customer.The customer did not provide any further information regarding those patients received magnesium treatment.Laboratory reference range for magnesium=1.8 to 2.6 mg/dl; critical low=0.9 mg/dl; high=4.9 mg/dl no further impact to patient management.

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 magnesium reagent, lot number 43489ud00.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.Based on the information provided, the cross functional team have determined that this is an adverse event due to use error.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 magnesium reagent, lot number 43489ud00 was identified.Updated section: outcomes attributed to ae: corrected from required intervention to serious injury.

• 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: 16428899
• MDR Text Key: 310091812
• Report Number: 3005094123-2023-00051
• Device Sequence Number: 1
• Product Code: JGJ
• UDI-Device Identifier: 00380740176532
• UDI-Public: 00380740176532
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181748
• 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: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2023
• Device Model Number: 08P1934
• Device Catalogue Number: 08P19-34
• Device Lot Number: 43489UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Outcome(s): Required Intervention; Other