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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM DEXCOM G5 RECEIVER; CONTINUOUS GLUCOSE MONITOR
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DEXCOM DEXCOM G5 RECEIVER; CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number G5
Device Problems Premature Discharge of Battery (1057); Detachment Of Device Component (1104); Component Falling (1105); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2017
Event Type  Injury  
Event Description
Using dexcom g5.Transmitter has 3 month battery life.It is supposed to give a 21 day notice when battery is getting low so that a new one can be ordered.Got first alert on (b)(6) 2016.Got a second alert early in the day on (b)(6) 2016 which said "21 days left." got 3rd alert later that day, then it died.Called company.As it was time for replacement, ordered new transmitter.Unfortunately, due to lack of sufficient warning, i was without cgm for 9 days as this happened while on vacation and we do not have mail delivery where we were staying.My complaint is that there is supposed to be a 3 week warning and it died in 2 days.In addition, i have had recent receiver issues which i reported in a separate report.Although i have used dexcom for many years and they have always been reliable, i find the fact that i have had 3 problems in less than 3 months a bit unnerving! i realize that technology has it's bugs, but this seems like an unusual amount of error for one company in a short period of time, or else, i'm just unlucky.
 
Event Description
Add'l info received on (b)(6) 2017 for mw5067187: dexcom g5 receiver - transmitter died so receiver was turned off for a week, because it kept alarming.When tried to restart, receiver would not leave start up screen.Company is replacing it.This receiver was a replacement.In (b)(6), i turned the previous receiver off over night as my sensor fell out during the night.When i tried to restart with new sensor in the am, i got a message, called tech support." when i called, they said it had to be replaced (this is the one that broke yesterday.) i was told not to turn off as people were having problems turning it on after it gets turned off.
 
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Brand Name
DEXCOM G5 RECEIVER
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM
MDR Report Key6245294
MDR Text Key64790149
Report NumberMW5067187
Device Sequence Number0
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 01/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberG5
Was Device Available for Evaluation? Yes
Type of Device Usage N
Patient Sequence Number1
Treatment
CALCIUM. ; LIPITOR.; LOSARTAN/HCTZ; OMEPRAZOL; OTC MEDS: MULTIVITAMIN; RX MEDS: HUMALOG; SPIRONALACTONE; VITAMIN D; ZANTAC
Patient Age56 YR
Patient Weight81
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