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

Model Number	MMT-7020A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This is the second sensor that i had to replace today (medtronic guardian sensor (3)).During calibration, sensor was reading 72 actual blood sugar was 111.Sensor was reading between 60-72 for 2 hours.I have contacted medtronic several time because i believe that there is an issue with lot hg50luf.I have three boxes of this same lot number, three sensor of the first box failed and now 2 sensors of the second box.I am sending the sensor where the clear plastic part did not separate from the tap back to medtronic as well as the remaining two sensors in the box.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC GUARDIAN SENSOR (3)
• Common Device Name: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 11505326
• Report Number: MW5100023
• Device Sequence Number: 3829414
• Product Code: MDS
• UDI-Device Identifier: 20763000337005
• UDI-Public: 20763000337005
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/14/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/15/2022
• Device Model Number: MMT-7020A
• Device Lot Number: HG50LUF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2021
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 86