MAUDE Adverse Event Report: SENSEONICS, INC. EVERSENSE CGM; CONTINUOUS GLUCOSE MONITOR, IMPLANTED ADJUCTIVE USE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/28/2020

Event Type  Injury  

Event Description

I passed out when the glucose reading was 65 on my eversense cgm.I am experiencing deviations of 50-80 points between fingerstick and cgm reading.The company is refusing to replace the product.Fda safety report id# (b)(4).

• Brand Name: EVERSENSE CGM
• Type of Device: CONTINUOUS GLUCOSE MONITOR, IMPLANTED ADJUCTIVE USE
• Manufacturer (Section D): SENSEONICS, INC.
• MDR Report Key: 9818406
• MDR Text Key: 183343110
• Report Number: MW5093671
• 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: 03/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 79