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

Model Number REF MMT-7020

Device Problems Loss of Power (1475); Calibration Problem (2890)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

It's ongoing; my daughter is diabetic, she has the 670g closed loop system.The guardian sensor is absolute garbage and it irritates me to end that the fda allowed something like this to go to market when there is something like dexcom g6 on the market that is far superior.This isn't comparing a cheap car vs a nice car.They are both supposed to save a diabetics life.Yet the guardian sensor, even if it does work correctly, which is not often, is constantly asking for input, where the g6 there are people that rarely even enter blood sugars.Example, daughter wakes up, pump showing 62, check blood sugar, because i can never trust the numbers with the guardian sensor, she's over 400.She was sleeping for no hours, no carbs, nothing should have been making blood sugars shoot up or down.What does medtronic say? "was she sleeping on it?" really that's a thing with their sensor? then why is it on the market.If it's more than 8% off on calibration it shuts down, if you enter two numbers more than twice it needs a new sensor.It is supposed to last 7 days it lasts 2 or 5, but never 7.Not unless you reset it, which you're not supposed to do.Howe about you do this.Since y'all approved this, ask for this data.How many sensors have they used in the us and how many sensors have they had to send out for free due to an issue.Fda safety report id# (b)(4).

• Brand Name: GUARDIAN SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 8716972
• MDR Text Key: 148787641
• Report Number: MW5087477
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 06/17/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2020
• Device Model Number: REF MMT-7020
• Device Lot Number: HG34QQB
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 11 YR
• Patient Weight: 43