MAUDE Adverse Event Report: MEDTRONIC ENLIGHT SENSOR

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.

• Brand Name: ENLIGHT SENSOR
• Type of Device: ENLIGHT SENSOR
• Manufacturer (Section D): MEDTRONIC; st. paul MN
• MDR Report Key: 6916162
• MDR Text Key: 88703501
• Report Number: MW5072622
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/13/2017
• Device Lot Number: HG1W524
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 82