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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC ENLIGHT SENSOR

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MEDTRONIC ENLIGHT SENSOR Back to Search Results
Lot Number HG1W524
Device Problems Failure to Charge (1085); No Display/Image (1183)
Patient Problems Hypoglycemia (1912); Concussion (2192); Loss of consciousness (2418)
Event Date 08/04/2017
Event Type  Injury  
Event Description
Continuous glucose monitor stopped reporting, resulting in severe low blood sugar and ems visit. Device failed to report low sugar. Removed and recharged only to discover recharge unsuccessful. Reported problem to mfg, but they cannot ship replacement for 2-4 months. They also refused to sell me an upgrade. This failure also resulted in a 2nd emt visit! a third incident with no emt but which caused a concussion from passing out. There was another incident, without emt or injury. Is the product compounded: no. Is the product over-the-counter: no. Frequency: continuous. How was it taken or used: inserted to skin. Date the person first started taking or using the product: (b)(6) 2015. Date the person stopped taking or using the product: (b)(6) 2017. Why was the person using the product: diabetic, used to monitor sugar levels.
 
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Brand NameENLIGHT SENSOR
Type of DeviceENLIGHT SENSOR
Manufacturer (Section D)
MEDTRONIC
st. paul MN
MDR Report Key6916162
MDR Text Key88703501
Report NumberMW5072622
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/13/2017
Device Lot NumberHG1W524
Was Device Available for Evaluation? No Answer Provided
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: 10/05/2017 Patient Sequence Number: 1
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