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U.S. Department of Health and Human Services

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

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MEDTRONIC MINIMED GUARDIAN SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7020
Device Problem Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 06/26/2019
Event Type  Injury  
Event Description
The sensor started getting hot and then burnt my arm, causing me to have to remove the sensor immediately. Fda safety report id # (b)(4).
 
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Brand NameGUARDIAN SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key8790299
MDR Text Key151174810
Report NumberMW5088075
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 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/18/2020
Device Model NumberMMT-7020
Device Catalogue NumberMMT-7811NA
Device Lot NumberHG394CZ
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/12/2019 Patient Sequence Number: 1
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