MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G7 SENSORS; SENSOR, GLUCOSE, INVASIVE

Model Number G7

Device Problems Defective Alarm (1014); Product Quality Problem (1506); Device Sensing Problem (2917); Wireless Communication Problem (3283)

Patient Problem Hypoglycemia (1912)

Event Date 06/20/2023

Event Type  Injury  

Event Description

Dexcom g7 3 out of 6 sensors failed within 2 hours, the other 3 sensors lost connection to the reader for hours at a time and then filled in the missing information when they regained connection since the information is used for treatment information.I am not able to trust the information to determine how much insulin to take.This is a failure of the purpose of the medical device so it is not usable.Medicare pays quite a bit for these sensors and is being ripped off.The device did not alarm for a low blood sugar and that could allow me to go into a coma or to die.This failure is dangerous.Reference reports: #mw5118742, #mw5118743, #mw5118745, #mw5118746, #mw5118747, #mw5118748.

• Brand Name: DEXCOM G7 SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 17198120
• MDR Text Key: 317946502
• Report Number: MW5118744
• Device Sequence Number: 1
• 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
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G7
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White