MAUDE Adverse Event Report: DEXCOM DEXCOM G5 MOBILE; SENSOR, GLUCOSE, INVASIVE

Device Problems Device Alarm System (1012); Noise, Audible (3273)

Patient Problem Tinnitus (2103)

Event Date 03/05/2018

Event Type  Injury  

Event Description

Using dexcom's g5 phone app to monitor my cgm, when blood sugar rises or drops to a given level, the app sounds an alarm at the loudest possible volume of the phone (regardless of the phone's current volume setting which could also be vibrate or silence).The alarm goes off no matter what.I was on the phone, with the phone held to my ear, when it went off.The sound was so deafening loud, that i experienced diminished hearing along with ringing in that ear for several hours after the event occurred.I have reached out to dexcom several times and have not heard anything back from them.Also, because the app does not follow the phone's setting for volume (volume level, vibrate, or mute), when at an event such as a wedding, funeral, conference, and so on, your only choice is to power off the phone during the event, which means that for that period of time you no longer have access to your current blood sugar levels, which could be dangerous should your levels drop or rise.The date listed above is an approximate date as the problem is ongoing and occurs anytime your blood sugar levels rise/fall.

• Brand Name: DEXCOM G5 MOBILE
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 7402266
• MDR Text Key: 104744329
• Report Number: MW5076357
• 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: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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): Other
• Patient Age: 52 YR
• Patient Weight: 88