MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC 670G INSULIN PUMP; AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number 670G

Device Problems Crack (1135); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 09/11/2020

Event Type  Injury  

Event Description

I just found out about this.I wear a medtronic 670g insulin pump and cgm.I've now had the pump replaced for the 4th time due to a crack on the back of the insulin pump leading to complete pump failure.The cgm fails prematurely and gives very inaccurate readings.This has caused me to have severe low blood sugar with seizures.The cgm says the glucose is 100 but the actual blood glucose is 40.There are many customers with this same problem.I think medtronic is covering up the reports.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC 670G INSULIN PUMP
• Type of Device: AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 10534902
• MDR Text Key: 207159595
• Report Number: MW5096605
• Device Sequence Number: 2
• Product Code: OZP
• 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: 09/11/2020
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 670G
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 47 YR
• Patient Weight: 66