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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 Hypoglycemia (1912)
Event Date 06/08/2022
Event Type  Injury  
Event Description
Senseonics was made aware of a hypoglycemia event and user complained of sensor inaccuracies.User reported that the event happened on (b)(6) 2022 at around 6 am.The measured blood glucose was 61 mg/dl and the sensor reading was 235 mg/dl.User did not receive any 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.Based on the investigation analysis, there was a wound reported at the insertion site after the sensor was inserted on (b)(6) 2022.The wound at the insertion site was reported around the same time as the event was reported, on june 8.The wound may have contributed to temporary noise in the optical channel which in turn, may have caused temporary mismatch between the sensor readings and fingerstick measurements.Therefore the user experienced temporary differences between the sensor readings and fingerstick measurements.As the user was leaving for vacation, there was limited data following the event to analyze further.No further investigation was possible for this complaint.
 
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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 Key19009408
MDR Text Key338980280
Report Number3009862700-2024-00353
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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