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U.S. Department of Health and Human Services

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

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MEDTRONIC MINIMED 670G GUARDIAN SENSORS SENSOR, GLUCOSE, INVASIVE Back to Search Results
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).
 
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Brand Name670G GUARDIAN SENSORS
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key8744155
MDR Text Key149688425
Report NumberMW5087683
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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  
0 Patients were Involved in the Event:
Date FDA Received06/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/10/2019
Device Catalogue NumberREF MMT-7020
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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