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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR; SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM G6 SENSOR; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number G6
Device Problems Defective Device (2588); Data Problem (3196)
Patient Problem Insufficient Information (4580)
Event Date 04/14/2021
Event Type  malfunction  
Event Description
A dexcom g6 sensor failed on the seventh day during its ten days programed life spam.During the sensor's failure, there is no data transmitted to my receiving device so that i have no continuous readings of my glucose level.Subsequently, i removed the failed sensor and installed another sensor that was available on hand.During a previous failure without another sensor on hand, i used glucose strips and a glucose meter until dexcom shipped a warranty sensor replacement.This is the third dexcom g6 sensor failure this year that i reported to dexcom for a warranty sensor replacement: yesterday, once in (b)(6) 2021, and once in (b)(6) 2021.The three defective sensors thus far this calendar year to only (b)(6) compared to only 1 defective sensor in calendar year 2020 is totally alarming.Fda safety report id# (b)(4).
 
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Brand Name
DEXCOM G6 SENSOR
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11693048
MDR Text Key246510499
Report NumberMW5100853
Device Sequence Number4
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 04/15/2021
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberG6
Device Catalogue Number9500-45
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age67 YR
Patient Weight73
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