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

Model Number MMT-7020

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 03/13/2022

Event Type  malfunction  

Event Description

I am using a medtronic 670g with the guardian 3 sensors for glucose monitoring and control.I have been experiencing an extreme failure rate with the guardian 3 sensors.The main problem begins with the insertion and calibration of the sensor.The insertion and the first calibration go well but starting within 2 hours the reported glucose values will be well outside of an acceptable error range, (sensor reporting 54, blood glucose finger stick reading 107 for one example).During the 2-48 hour insertion window the accuracy range of the sensor varies for less than 5% to well over 50%.Since this device is delivering insulin depending on the information from the sensor, this can cause life threatening issues.If the sensor were to read high and deliver what it believed to be a correcting bolus of insulin and i was actually in a low glucose situation this would be life threatening.This has been an ongoing issue with the guardian 3 sensor since i moved over to this system last october.Multiple conversations with medtronic and my endocrinologist have failed to resolve the issue.I have went through multiple layers of trouble shooting with medtronic tech support, they replaced the guardian 3 transmitter at one point.Their sole remedy to the situation is to simply keep replacing the defective sensor.Fda safety report id # (b)(4).

• Brand Name: GUARDIAN SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 13798008
• MDR Text Key: 287433347
• Report Number: MW5108207
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 20763000336985
• UDI-Public: (01)20763000336985(17)230208(10)
• 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: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/08/2023
• Device Model Number: MMT-7020
• Device Lot Number: HG5U7WA
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2022
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; CLOPIDOGREL ; LISINOPRIL ; MULTI ; NOVOLOG ; VITAMIN C; VITAMIN D
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White