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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 Problems Use of Device Problem (1670); Output Problem (3005); Pumping Problem (3016)
Patient Problem Insufficient Information (4580)
Event Date 04/11/2021
Event Type  Injury  
Event Description
Unable to use pump automode; the glucose sensor stopped working about 2 days early. This has happened with this product frequently before. The site was inserted and used as instructed with several years of experience. I kept getting an error "sensor updating - do not calibrate" on my insulin pump and it stopped and said changed after about 6 hours, causing it to need to be changed almost 2 days early, which i couldn't do given time (late night/ early morning. ). Fda safety report id # (b)(4).
 
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Brand NameGUARDIAN SENSOR (3)
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key11669682
MDR Text Key245845691
Report NumberMW5100786
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/18/2022
Device Model NumberMMT-7020
Device Lot NumberHG50RYV
Was Device Available for Evaluation? No
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

Patient Treatment Data
Date Received: 04/14/2021 Patient Sequence Number: 1
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