MAUDE Adverse Event Report: ASCENSIA/SENSEONICS / SENSEONICS, INC. EVERSENSE XL; CONTINUOUS GLUCOSE MONITOR, IMPLANTED, ADJUNCTIVE USE

Model Number EVERSENSE XL

Device Problems Product Quality Problem (1506); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 04/16/2022

Event Type  Injury  

Event Description

Eversense cgm not accurate; eighty two days ago i switched from the dexcom g6 cgm to the eversense xl.The unit constantly reports low sugar when it is not low.It needs to be calibrated constantly at all hours of the day and night.If you miss a calibration, then you need to re-calibrate 4 times over 8 hours.Transmitter disconnects all the time.This item was designed to be broken and i think the vendor knew that.And finally the app says to never use the eversense to make medical decisions like when needing insulin.If that is the case, what is the use of having this expensive device.The bottom line is, the eversense is just produced to make money and does not help at all with diabetes management.Fda safety report id# (b)(4).

• Brand Name: EVERSENSE XL
• Type of Device: CONTINUOUS GLUCOSE MONITOR, IMPLANTED, ADJUNCTIVE USE
• Manufacturer (Section D): ASCENSIA/SENSEONICS / SENSEONICS, INC.
• MDR Report Key: 14161664
• MDR Text Key: 289751729
• Report Number: MW5109179
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/16/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/24/2022
• Device Model Number: EVERSENSE XL
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2022
• Patient Sequence Number: 1
• Treatment: AMOXI-CLAV 875-125 MG ; CLOPIDGREL 75 MG ONCE PER DAY AM ; COATED ASPIRIN 81 MG TAB ONCE PER DAY AM ; DULOXETINE 30 MG ONCE PER DAY AM ; FENOFIBRATE 48MG TAB 2 X 48MG ONCE PER DAY AM; FIASP 60 UNITS SLIDING MEALS 3X TO 4X A DAY; HYDROCHLOROTHIAZIDE TAB 25MG 1/DAY AM ; JARDIANCE 25MG ONCE PER DAY AM ; LOSARTAN 100MG ONCE PER DAY AM ; METOPROLOL 50MG ONCE PER DAY PM ; OMEGA-3 ETHEL ESTERS 1GM 2GM AM 2GM PM; REPATHA INJECTION 140MG EVERY TWO WEEKS ; TRESIBA U-200 150 UNITS AM ; TWICE PER DAY AM-PM ; VITAMIN D3 2000 IU 1/DAY AM
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White