MAUDE Adverse Event Report: MEDTRONIC MINIMED GUARDIAN SENSOR; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7020

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 06/26/2019

Event Type  Injury  

Event Description

The sensor started getting hot and then burnt my arm, causing me to have to remove the sensor immediately.Fda safety report id # (b)(4).

• Brand Name: GUARDIAN SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 8790299
• MDR Text Key: 151174810
• Report Number: MW5088075
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/18/2020
• Device Model Number: MMT-7020
• Device Catalogue Number: MMT-7811NA
• Device Lot Number: HG394CZ
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 132