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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC ENLITE SENSOR

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MEDTRONIC MEDTRONIC ENLITE SENSOR Back to Search Results
Model Number 530G PUMP MODEL 551
Device Problem Invalid Sensing (2293)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 01/18/2018
Event Type  Injury  
Event Description
Pt is wearing a medtronic sensor and is using it per the instructions. At times the sensors is 100's of points off. The patient has called medtronic several times and the sensors are not accurate. Pt has type 1 diabetes and is on the medtronic insulin pump with a medtronic sensor and he makes decisions about eating, not eating, and insulin dosing with his sensors and it is so inaccurate at the beginning and end of the sensors cycle that it could be fatal.
 
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Brand NameMEDTRONIC
Type of DeviceENLITE SENSOR
Manufacturer (Section D)
MEDTRONIC
MDR Report Key7221600
MDR Text Key98462299
Report NumberMW5074895
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
Type of Report Initial
Report Date 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number530G PUMP MODEL 551
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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: 01/25/2018 Patient Sequence Number: 1
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