MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC GUARDIAN SENSOR (3); SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7020A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2021

Event Type  Injury  

Event Description

I was setting up to insert a new medtronic guardian sensor (3) when a clear plastic part of the sensor did not separate from the tap.I have had several issues with this lot number of sensor so i did not want to use the sensor and have it fail.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC GUARDIAN SENSOR (3)
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 11506763
• MDR Text Key: 240691108
• Report Number: MW5100049
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 20763000337005
• UDI-Public: 20763000337005
• 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: 03/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/15/2022
• Device Model Number: MMT-7020A
• Device Lot Number: HG50LUF
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 86