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U.S. Department of Health and Human Services

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

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SENSEONICS INC. EVERSENSE SMART TRANSMITTER; IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER Back to Search Results
Model Number 102208-750
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
This report is being submitted retrospectively as part of internal review.A corrective and preventive action (capa) was opened by senseonics which investigated the issue and the root cause was identified to be battery deep discharge leading to a battery swell and thermal run away.As part of corrective action, additional manufacturing controls were put in place to ensure only batteries within spec are used in transmitter assembly.Additional screening procedure was implemented for battery voltage and capacity.As part of preventive action, senseonics implemented battery voltage and current trend data monitoring by lot number at the supplier end to ensure ongoing battery health status within lots.
 
Event Description
Senseonics was made aware of a incident where patient complained that transmitter exploded while charging.Patient said that 2-3 days before he noticed that the transmitter takes a long time to charge.On the day of incident, patient put the transmitter for charging and was watching tv in another room.After about 20 minutes, he heard a loud bang.Transmitter button was missing.
 
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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 Key19009418
MDR Text Key338980168
Report Number3009862700-2024-00356
Device Sequence Number1
Product Code QCD
Combination Product (y/n)Y
Reporter Country CodeGM
PMA/PMN Number
P160048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/31/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/02/2022
Device Model Number102208-750
Device Catalogue NumberFG-3400-50-001
Device Lot Number122419
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/31/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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