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

Device Problems Break (1069); Crack (1135); Incorrect, Inadequate or Imprecise Result or Readings (1535); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Date 09/25/2019

Event Type  Injury  

Event Description

I currently use a medtronic 670g insulin pump.The pump has a (cgm) continuous glucose monitor.The pump uses an "auto mode" feature that will increase or decrease insulin depending on my blood sugar levels.I have been on this pump since (b)(6) 2018 and have been through a total of 8 pumps due to malfunctioning, cracked buttons and broken casings.I keep this pump in a specialized case on my hip and have never damaged a pump.These insulin pumps have constantly given me false blood glucose readings with the cgm.Last month while on the insulin pump every night around 10pm i would have to drink a high sugar drink to bring my blood glucose to around 200-220 mg/dl and go to bed like this.If i were to go to bed with my blood glucose at a normal level 100-120 mg/dl, i would wake up a few hours later to my insulin pump alarming with severe low blood sugars 60-40 mg/dl and would have to wake my wife.I cannot feel when my blood sugar is starting to get low until it's very low around 50 mg/dl.This went on for a month, after many contacts with medtronic they finally sent me a new insulin pump.The same model a 670g, every day this pump gives me false readings and has made me sick and has put me in the hosp.Diabetes as myself rely on this approved technology to help with our diabetes not make it worse.This pump is not helping me.My readings will state on my insulin pump 165 mg/dl and when checking on multiple meters they will be over 300 mg/dl.Or my insulin pump will show i'm at 95 mg/dl and i'm over 250 mg/dl.When the insulin pump shows it's within range 80-120 mg/dl it will not give me insulin.But in actually i do need the pump to give me insulin because i am not in range.I am over 200-300 mg/dl.It also does it with lows, alerting me when i'm at 90-70 mg/dl, but i am much lower in the 40-50 mg/dl.I have had many sensors replaced, spoken with medtronic regarding this issue, been to training on this and have spoken with medtronic training over the phone and i am doing things 100% by the book and correct.I have been type 1 diabetic for 16 years.These medtronic pumps and cgm systems are doing this to many people.I am in a diabetic group with around 30,000 type 1 diabetics and this is the main topic.Many have the same issues i have as well.I have a lot of pictures, i have taken and saved on my phone showing these issues.This insulin pump and cgm showing huge numbers off is very bad for my health and causing me to feel very sick and in pain often.This issue really needs to be looked into.I am currently trying to get off this pump and cgm and on to a different mfr (tandem and dexcom) but it's not looking too well because insurance does not want to supply pumps to diabetics but every 4-5 years.While my pump still does have just under 2 years left on the warranty my cgm is no longer under warranty.As stated i have been through 8 insulin pumps and 3 cgm transmitters and currently using the "most updated versions of both".Yet they have problems, 8 pumps and 3 transmitters in 2 years is outrageous especially when i send these back for replacement.They still look brand new like they came out of the box except they are broken or have a malfunction.These pumps are dangerous and something really needs to be done about this.Medtronic is no help, the dr cannot do anything more, so where do i and many others turn? i would appreciate someone contacting me to see what can be done about this issue.I would love to get off this pump or have the issue resolved.Thank you - (b)(6).Fda safety report id# (b)(4).

• Brand Name: GUARDIAN SENSOR 3 SENSOR GLUCOSE, INVASIVE
• Type of Device: GUARDIAN SENSOR 3 SENSOR GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 9632343
• MDR Text Key: 176639591
• Report Number: MW5092513
• Device Sequence Number: 9
• 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: 01/21/2020
• 11 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 32 YR
• Patient Weight: 79