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

Model Number 102208-500

Device Problem Device Alarm System (1012)

Patient Problem Hyperglycemia (1905)

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

No further follow up possible from the user so the malfunction could not be confirmed.

Event Description

On (b)(6) 2019, senseonics was made aware of an adverse event where the user experienced a hyperglycemia event.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): SENSEONICS INC; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: sachin thanawala ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 8972643
• MDR Text Key: 156871434
• Report Number: 3009862700-2019-00104
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491021441
• UDI-Public: 00817491021441
• Combination Product (y/n): N
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2019

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: 12/11/2019
• Device Model Number: 102208-500
• Device Catalogue Number: FG-3300-01-001
• Device Lot Number: 111294
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR