MAUDE Adverse Event Report: DEXCOM DEXCOM G5; DEXCON G5

Model Number DEXCOM G5 DX74103048

Device Problem Device Alarm System (1012)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 03/27/2018

Event Type  Injury  

Event Description

I am on the dexcom g5, lot number 5231430, i have used it for almost 3 months.There have been several times that i have had a high glucose and the dexcom g5 did not alert me or it was delayed.I have had several lows and it did not alert me.On (b)(6) 2018 i was at work climbing up and down a ladder and my sugar had dropped to 32.The dexcom did not alert me at all, i can't tell when my sugar drops or goes high.I have tested the alerts every night when i plug the device in to charge.Vibration and sound work perfectly.I have also noticed that the sensor has trouble staying connected via bluetooth to the device.I'm not sure as what to do.This could have been a serious case of hospitalization due to the failure of the device.I have talked to one gentleman at (b)(6) they told me that if the device has sound and vibration then it's working properly.I am a mother of three working to support my family.One income as my youngest daughter has medical issues that prevent her from going to day care.So if i had gotten hurt by falling or passing out due to my sugar dropping or going too high my family would be out on the streets.(b)(6).

• Brand Name: DEXCOM G5
• Type of Device: DEXCON G5
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 7384664
• MDR Text Key: 104084002
• Report Number: MW5076222
• 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: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/11/2017
• Device Model Number: DEXCOM G5 DX74103048
• Device Catalogue Number: MT22949
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 32 YR
• Patient Weight: 70