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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CGM; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
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DEXCOM, INC. DEXCOM G6 CGM; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED Back to Search Results
Model Number G6
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
Event Date 02/06/2021
Event Type  Injury  
Event Description
I have type 1 diabetes and use dexcom g6 cgm device to monitor sugars.Users change their sensor every ten days.I've noticed and complained to dexcom that within 48 hours of expiration, the sensor often does not transmit data.On this instance, the sensor was intermittently transmitting.It erroneously indicated i had a bg of 51.I acted to treat the low bg.Then, about 45 minutes later, i got another low alert and treated again.I started to feel poorly like i had high glucose.I tested with a finger stick and the finger stick revealed a difference of 150 points between what the sensor measured and what i measured with a finger stick.If i had not caught this when i did, i could have ended up in dka and in the er.The cgm was reading 51 mg/dl and my actual blood glucose was 273 mg/dl.Fda safety report id # (b)(4).
 
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Brand Name
DEXCOM G6 CGM
Type of Device
INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11307248
MDR Text Key231582498
Report NumberMW5099311
Device Sequence Number2
Product Code QBJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/07/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberG6
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age49 YR
Patient Weight84
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