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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED GUARDIAN SENSOR (3) SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED GUARDIAN SENSOR (3) SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7020
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/06/2018
Event Type  malfunction  
Event Description
I am currently own a medtronic minimed 670g resulting pump system that includes their guardian link continuous glucose monitoring system. I experienced two quality issues with the cgm system on this day. The first sensor insert's needle remover device did not unlock from the sensor properly, and in turn as i pulled the removal device, it pulled the entire sensor out of the area i inserted it. This of course rendered the sensor device useless. I inserted a 2nd new sensor device and it went fine until the sensor would not calibrate properly and i was instructed to remove it. Since late (b)(6) i have had a total of two boxes of 5 sensors per box that i have used. Out of those 10 sensors, 4-5 have been bad or had quality issues such as mentioned above. Where i am from those are not good statistics.
 
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Brand NameGUARDIAN SENSOR (3)
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key7502125
MDR Text Key108095495
Report NumberMW5077096
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 05/07/2018
5 Devices were Involved in the Event: 1   2   3   4   5  
0 Patients were Involved in the Event:
Date FDA Received05/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2019
Device Model NumberMMT-7020
Device Lot NumberD018
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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