MAUDE Adverse Event Report: MEDTRONIC MINIMED 670G GUARDIAN SENSORS; SENSOR, GLUCOSE, INVASIVE

Catalog Number REF MMT-7020

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2019

Event Type  malfunction  

Event Description

I currently use a medtronic 670g insulin pump.The sensors are designed to last 7 days, but seldom last more than 5 and many fail within the first few days.On average, at last 1 sensor fails (often 2) after a few days per box.Medtronic swears it's from wet or loose tape, however, i've had multiple training sessions and doubled up tape to no avail.Per the forums and my dr, this is not uncommon and sensor problems have plagued this device.In the past, medtronic simply replaced them free of charge (just send the failed sensors in for replacements), now you must call immediately when a sensor fails to get a replacement.They either have a product design issue or a mfg issue.I alone have had close to 20 failures over the past two years.I have collected the most recent batch of failed sensors (6 over 3 months) and kept the most recent boxes if you need the numbers of them.Fda safety report id# (b)(4).

• Brand Name: 670G GUARDIAN SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 8744155
• MDR Text Key: 149688425
• Report Number: MW5087683
• Device Sequence Number: 5
• 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: 06/25/2019
• 20 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: REF MMT-7020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 113