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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 NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11693048
MDR Text Key246510499
Report NumberMW5100853
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000255
UDI-Public00386270000255
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
Device Expiration Date11/12/2021
Device Model NumberG6
Device Catalogue Number9500-45
Device Lot Number5281862
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: 04/19/2021 Patient Sequence Number: 1
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