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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 102208-750
Device Problem Imprecision (1307)
Patient Problem Hypoglycemia (1912)
Event Date 12/07/2021
Event Type  Injury  
Manufacturer Narrative
This report is being submitted retrospectively as part of an internal review.Ased on the investigation of the event on (b)(6) 2021, there was inherent lag in the sensing technology of the sensor and that the sensor glucose eventually caught up to the calibration (capillary) entry after 3-4 sensor readings.The investigation of the event on (b)(6) 2021 showed that the system was not within the 20/20 error target of the system.But this is not due to a system failure, and it was within the 30/30 error bounds of the cgm system, this occasional occurrence is still consistent with normal system operation.The system did not assert the hypo alert as the sensor readings did not cross the low glucose alert threshold at the time of the event.
 
Event Description
On (b)(6) 2021, senseonics was made aware of a hypoglycemia event where user complained of not receiving low glucose alerts.The event occurred on (b)(6) 2021 at 02:23 am.The blood glucose (bg) value was 51 mg/dl where as sensor glucose (sg) value was 84 mg/dl.User was symptomatic (cravings, sweat, racing heart, dizziness).User did not receive alerts because the low alert threshold was set at 60 mg/dl and sg value did not cross it.User did not require any medical treatment and was able to self treat.
 
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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 Key19009472
MDR Text Key338981081
Report Number3009862700-2024-00299
Device Sequence Number1
Product Code QCD
UDI-Device Identifier00817491023087
UDI-Public817491023087
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? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date02/05/2022
Device Model Number102208-750
Device Catalogue NumberFG-3400-50-001
Device Lot Number122491
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/19/2022
Initial Date FDA Received03/31/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2021
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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