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U.S. Department of Health and Human Services

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

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DEXCOM DEXCOM G5 MOBILE SENSOR, GLUCOSE, INVASIVE Back to Search Results
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.
 
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Brand NameDEXCOM G5 MOBILE
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM
MDR Report Key7402266
MDR Text Key104744329
Report NumberMW5076357
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received04/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/05/2018 Patient Sequence Number: 1
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