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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

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SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM Back to Search Results
Model Number 102096-67A
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2021
Event Type  Injury  
Manufacturer Narrative
This mdr is result of a retrospective review of complaints.The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
 
Event Description
On 30 march 2021, senseonics was made aware of an incident where user complains of having low signal within the transmitter and sensor, leading to early sensor removal as the patient was having issues with placement guide weak connection.
 
Manufacturer Narrative
The customer complaint could not be confirmed as sensor communicated throughout the in-vitro qc test as well as during the two other above-described tests.The potential root cause of the inability of the customer to get a "good/excellent" signal is that the sensor was too deeply inserted in her arm as could be read in the case notes.This case was initially dispositioned as non-complaint and re-dispositioned as complaint per ntf-0456.As part of resolution, the rma was authorized to offer the user a sensor replacement.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 67.
 
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Brand Name
EVERSENSE SENSOR
Type of Device
EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
Manufacturer (Section D)
SENSEONICS INC.
20451 seneca meadows parkway
germantown MD 20875 7005
Manufacturer (Section G)
SENSEONICS INC.
20451 seneca meadows parkway
germantown MD 20875 7005
Manufacturer Contact
vallikannu somasundaram
20451 seneca meadows parkway
germantown, MD 20875-7005
MDR Report Key13556537
MDR Text Key285805253
Report Number3009862700-2022-00033
Device Sequence Number1
Product Code QCD
UDI-Device Identifier00817491022349
UDI-Public817491022349
Combination Product (y/n)Y
Reporter Country CodeUS
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 03/30/2021
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 Date03/10/2021
Device Model Number102096-67A
Device Catalogue NumberFG-4200-00-301
Device Lot NumberWP07834
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/30/2021
Initial Date FDA Received02/18/2022
Supplement Dates Manufacturer Received03/30/2021
Supplement Dates FDA Received02/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age40 YR
Patient SexFemale
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