MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number 102208-500

Device Problems Imprecision (1307); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Encephalopathy (1833); Hypoglycemia (1912)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On october 29th 2020, senseonics was made aware of an adverse event where patient was hospitalized due to hypoglycemia with acute metabolic encephalopathy.

Manufacturer Narrative

The case notes clearly indicate that this incident has nothing to with device, insertion procedure or study procedure.Besides, the user was inserted on 27th october and date of event is 28th october.Once a customer is inserted with new sensor (i.E.27th october) there is a 24 hour warm up period during which no calibration is possible.After 24 hour warm up period, customer must put in 4 calibrations 2-12 hours apart and system starts showing glucose data after 2nd calibration entry.Dms confirms that customer was inserted on sensor on 27th october but system did not come out of initialization step and display glucose values until 31st october.All the 4 calibrations required for system to come out of initialization step were entered on 31st october.This confirms that system was not in use and hence the event was not related to device.No further investigation is required.H6.Health effect - clinical code updated to 1833 h6.Health effect -impact code updated to 4614 h6.Medical device problem code updated to 2993 h6.Component code updated to 4756 h6.Type of investigation updated to 4111 h6.Investigation findings updated to 3221 h6.Investigation conclusions updated to 4310.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• MDR Report Key: 10915752
• MDR Text Key: 218643154
• Report Number: 3009862700-2020-00575
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• Combination Product (y/n): Y
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/17/2020
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 116481
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/28/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR