MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SMART TRANSMITTER; IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER

Model Number 102208-704

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The complaint was investigated, and investigation found some evidence of transitory sensor inaccuracy potentially caused by noise in optical channel.The sensor was replaced by customer care soon after the event.The customer was advised to use blood glucose meter for any treatment decision as indicated in user guide.

Event Description

Senseonics was made aware of an incident where patient experienced a hyperglycemia event.Patient reported that the sugar rose to over 300 mg/dl because of which she took the insulin.Eversense then showed a value of 171 mg/dl but the blood glucose meter showed 108 mg/dl.Patient did not share any further information except that she got a corona vaccination (biontech) in the vicinity of the sensor.The sensor was implanted on (b)(6) 2021.Patient drank juice and did not require any medical attention patient did not provide any further information.

• Brand Name: EVERSENSE SMART TRANSMITTER
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER
• 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: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18984587
• MDR Text Key: 338659800
• Report Number: 3009862700-2024-00199
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 03/27/2024

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: 07/29/2021
• Device Model Number: 102208-704
• Device Catalogue Number: FG-3400-04-001
• Device Lot Number: 119803
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other