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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM INC. DEXCOM G5 RECEIVER AND TRANSMITTER; CONTINUOUS GLUCOSE MONITOR SYSTEM
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DEXCOM INC. DEXCOM G5 RECEIVER AND TRANSMITTER; CONTINUOUS GLUCOSE MONITOR SYSTEM Back to Search Results
Model Number G5
Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Battery Problem (2885); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
Event Date 01/17/2017
Event Type  malfunction  
Event Description
Dexcom g5 continuous glucose monitor - multiple failures of product and insufficient support.Cgm transmitter failures: 2 since (b)(6) 2016.Cgm receiver hard failures: 2 since (b)(6) 2016.As a result, a "type one" diabetic was without continuous glucose monitoring for over three weeks.Consequence: a sharp decline in blood sugar control including severe hypoglycemic reactions and hyperglycemia.Detail: as a type one diabetic i rely heavily on the dexcom cgm device to maintain blood glucose levels.Removal of the device dictates an immediate lifestyle change and different methods are necessary to obtain diabetic control.Failures.The dexcom g5 failed in (b)(6) 2016 with an error code of "err121".Dexcom did send a replacement transmitter and receiver at that time.In (b)(6) 2017 a second failure with the same hard error code "err121." dexcom sent another replacement however the transmitter battery once again failed with no warning.(a battery failure with no warning is a serious occurrence because it leaves no time to get a replacement before losing cgm capabilities.) dexcom refused to send a replacement transmitter because they "reduced the warranty from "1 year down to 3 months" to compensate for the high rate of failures with their transmitters.Furthermore, support did not complete the job of getting cgm capabilities back to the patient, ergo the complete insurance process must be repeated through customer service for replacement, despite the problem being caused by product failure.Note: the internet is flooded with complaints about the unreliability of this product.(b)(6).Forty-five years experience with type one diabetes.Ten years experience with cgm devices - never experienced the failures prevalent with the dexcom 5.
 
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Brand Name
DEXCOM G5 RECEIVER AND TRANSMITTER
Type of Device
CONTINUOUS GLUCOSE MONITOR SYSTEM
Manufacturer (Section D)
DEXCOM INC.
MDR Report Key6282731
MDR Text Key66048594
Report NumberMW5067499
Device Sequence Number2
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
Report Date 01/25/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/25/2017
Is this an Adverse Event Report? No
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
ASPIRIN; DEXCOM G5 RECEIVER; DEXCOM TRANSMITTER; OTC MEDS: MULTIVITAMIN; RX MEDS: INSULIN
Patient Age56 YR
Patient Weight100
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