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

Model Number 102204

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Anxiety (2328)

Event Date 05/21/2019

Event Type  malfunction  

Event Description

Eversense cgm - 2nd device inserted with the inconsistencies and inaccuracies with blood sugar measurements.False starts and false lows causing unnecessary pricks for finger prick blood sugar testing.No two consecutive readings are stable but only peaks and valleys with big (30-40+ point) spikes and drops leading to unnecessary anxiety.I can provide downloaded charts from the glucometer.Fda safety report id# (b)(4).

• Brand Name: EVERSENSE CGM
• Type of Device: CONTINUOUS GLUCOSE MONITOR, IMPLANTED ADJUSTABLE
• Manufacturer (Section D): SENSEONICS, INC.
• MDR Report Key: 8640564
• MDR Text Key: 146233482
• Report Number: MW5086882
• 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: 05/21/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102204
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 59