MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CGM SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hypoglycemia (1912)

Event Date 12/30/2019

Event Type  Injury  

Event Description

Dexcom g6 sensor failure, resulted in hypoglycemia which required ambulance transport to ed, this makes eleven (11) sensor failures in the last twelve (12) months.Fda safety report id# (b)(4).

Event Description

Add'l info received from reporter on 12/31/2019 for report # mw5091947.Dexcom g6 sensor failure, resulted in hypoglycemia which required ambulance transport to ed, this makes thirteen (13) sensor failures in the last twelve (12) months.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 CGM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 9536111
• MDR Text Key: 173235979
• Report Number: MW5091947
• Device Sequence Number: 8
• Product Code: MDS
• 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,Followup
• Report Date: 12/30/2019
• 13 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 113