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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
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SENSEONICS INC. EVERSENSE TRANSMITTER; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM Back to Search Results
Model Number 102208-905
Device Problem Imprecision (1307)
Patient Problem Hypoglycemia (1912)
Event Date 10/15/2023
Event Type  Injury  
Event Description
Senseonics was made aware of a serious adverse event due to hypoglycemia which happened on (b)(6) 2023 at 2:32 pm.The event led to diabetic coma.The patient reported that the sensor glucose (sg) value at the time of event was 170 mg/dl and the measured blood glucose (bg) value was 50 mg/dl.The patient complained of not being alerted by eversense cgm system.The patient received medical treatment from the ambulance personnel who gave two iv drops.Patient was also prescribed medication (baqsimi, a nasal powder in single - dose container, indicated for treatment of severe hypoglycemia in adults).
 
Manufacturer Narrative
The preliminary analysis was performed on the user synced glucose data on data management system (dms), which is a cloud platform for eversense system.Based on the preliminary analysis, the sensor glucose (sg) value at 2:30 pm was 50 mg/dl.The user started receiving low glucose alerts at 2:23 pm when the sg value reached 49 mg/dl.The user kept receiving low glucose alerts every 15 minutes.The manufacturer is currently performing additional evaluation and the results will be provided in a supplemental report.
 
Manufacturer Narrative
The preliminary analysis was performed on the user synced glucose data on data management system (dms), which is a cloud platform for eversense system.Based on the preliminary analysis, the sensor glucose (sg) value at 2:30 pm was 50 mg/dl.The user started receiving low glucose alerts at 2:23 pm when the sg value reached 49 mg/dl.The user kept receiving low glucose alerts every 15 minutes.Ambulance personnel treated the patient by giving two iv drops to restore the blood levels as treatment.A review of the overall system performance did not reveal any malfunction and it was observed that the system was functioning as expected.Although the signal channel showed some degradation due to sensor approaching its end of life, the mean absolute relative difference (mard) was within normal bounds.Since the system functioned as expected during the time of the incident, this complaint does not require any further investigation.Date of this report update to (b)(6) 2024.Date received by manufacturer updated to (b)(6) 2023.Device manufacturer by manufacturer? yes.Investigation findings updated to 213.Investigation conclusions updated to 67.
 
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Brand Name
EVERSENSE TRANSMITTER
Type of Device
EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
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 Key18117194
MDR Text Key327886096
Report Number3009862700-2023-00233
Device Sequence Number1
Product Code QHJ
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,Followup
Report Date 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date06/28/2023
Device Model Number102208-905
Device Catalogue NumberFG-3500-05-001
Device Lot Number130325
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/29/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2022
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) Hospitalization;
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