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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 102208-751
Device Problem Imprecision (1307)
Patient Problem Hyperglycemia (1905)
Event Date 06/05/2022
Event Type  Injury  
Event Description
Senseonics was made aware of a hyperglycemia event and user complained of sensor inaccuracies.User reported that the event happened on (b)(6) 2022 at around 3 pm.The measured blood glucose was 237 mg/dl and the sensor reading was 110 mg/dl.User did not receive any high glucose alerts.User was symptomatic, but did not want to provide information regarding self treatment, medical treatment or if hospitalization was required.
 
Manufacturer Narrative
This report is being submitted retrospectively as part of internal review.The transmitter was not requested to be returned for evaluation as it was still being used by the user.The investigation was performed on the user's data available in data management system.The investigation confirmed the reported mismatch between bg and sg on (b)(6) 2022 as reported.Investigation revealed temporary noise in optical channel and customer complained of infection at insertion site which could have likely contributed to the reported mismatch.
 
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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 Key19009411
MDR Text Key338980421
Report Number3009862700-2024-00354
Device Sequence Number1
Product Code QCD
Combination Product (y/n)Y
Reporter Country CodeIT
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? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date10/07/2022
Device Model Number102208-751
Device Catalogue NumberFG-3400-51-001
Device Lot Number127178
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/31/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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