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

Model Number	670G
Medical Device Problem Codes	Crack (1135); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hypoglycemia (1912); Seizures (2063)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 10534902
• Report Number: MW5096605
• Device Sequence Number: 12383426
• Product Code: OZP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 09/11/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 670G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 47 YR
• Patient Weight: 66