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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 11/13/2023
Event Type  Injury  
Manufacturer Narrative
Manufacturer is currently performing evaluation and the results will be provided in the supplemental report.
 
Event Description
Senseonics was made aware of a false hypoglycemia event and the patient complained of inaccurate glucose readings.The patient reported that the sensor glucose (sg) reading was 49 mg/dl and the system asserted a low glucose alert.However, the patient did not have any low glucose symptoms.The patient did not check the blood glucose value and hence did not provide that information.The patient did not have to take any actions or seek any medical attention.
 
Manufacturer Narrative
The investigation was performed on the user synced glucose data on data management system (dms), which is an eversense cloud platform.Based on the investigation analysis, the sensor glucose (sg) value was 52 mg/dl at 11:18 am and 57 mg/d at 11:23 am.The customer did not enter blood glucose (bg) values at these times and as a result, the mismatches or discrepancy cannot be confirmed.The system asserted low glucose alerts at the time of incident since it went below the alert threshold.A review of the available glucose data on dms revealed symptoms consistent with situations where estimated values provided by the app (sg values) were entered as calibrations rather than true fingerstick bg entry.Customer was advised to not enter anything other than a true bg meter value, from a finger stick, when calibrating.Entering estimated values or values from the eversense cgm or another cgm, can disrupt the calibration and lead to significant deviations in the sensor readings.The customer continued to use the system until the sensor reached the end of life.No further investigation was found necessary for this complaint.B4.Date of this report 26 april 2024.G3.Date received by the manufacturer? 29 dec 2023.H3.Device evaluated by manufacturer? yes.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.
 
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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 Key18314253
MDR Text Key330308999
Report Number3009862700-2023-00823
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 04/26/2024
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 Date01/09/2024
Device Model Number102208-905
Device Catalogue NumberFG-3500-05-001
Device Lot Number135468
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/15/2023
Initial Date FDA Received12/12/2023
Supplement Dates Manufacturer Received12/29/2023
Supplement Dates FDA Received04/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2023
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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