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

Model Number	102208-610
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Hypoglycemia (1912); Laceration(s) (1946)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The system asserted a hypoglycemia alert to the user before the reported event.The device functioned as designed, thus no further investigation was required.According to the user, the reported event occurred after taking insulin which the user stated made the blood glucose drop too fast.The user took sugar to recover from hypoglycemia.The chin laceration caused by the fall was treated at the er with stitches, and no medication was prescribed.
Event or Problem Description
On (b)(6) 2023 senseonics was made aware of an adverse event where the user fell causing a chin laceration due to a hypoglycemia event.
Additional Manufacturer Narrative
The sensor measured glucose concentrations below the user's low-glucose threshold from 9:56 pm until 10:41 pm on (b)(6) 2023 and correctly triggered multiple "low glucose" alerts, which the user recalled receiving.The hypoglycemic event was therefore not missed, and there is no evidence to suggest a performance malfunction of the sensor.The user was evaluated at an er without admission to the hospital.Per case notes, the user did not receive any treatment.Since the device performed as expected by asserting appropriate alerts, no further resolution was found necessary for this complaint.

• Brand Name: EVERSENSE TRANSMITTER
• Common Device Name: 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 Key: 16924499
• Report Number: 3009862700-2023-00113
• Device Sequence Number: 6910456
• Product Code: QHJ
• UDI-Device Identifier: 00817491022929
• UDI-Public: 817491022929
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/27/2023
• Device Model Number: 102208-610
• Device Catalogue Number: FG-5901-01-001
• Device Lot Number: 129007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male