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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 7279759
Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Activation Problem (4042)
Patient Problem Unspecified Mental, Emotional or Behavioural Problem (4430)
Event Date 09/14/2020
Event Type  Injury  
Event Description
Patient called to report product issues with his dexcom sensors and transmitter. Patient stated that since he started the new dexcom g6 in august, he's had 4 sensor failures and 1 transmitter failure. Patient stated the sensors fail to read and provide readings and gives error messages requiring the sensor to be changed. Patient said he experienced a deployment failure with the transmitter. Patient said that he's contacted dexcom and requested to speak with executives but was directed back to regular customer service representatives. Patient said he is not happy with the level of customer service from dexcom. Patient stated that since he's a type 1 diabetic he had to revert to multiple finger sticks a day since the sensors kept failing and he didn't have a replacement one. Patient stated this has created some mental anguish for him. Patient also stated that it doesn't seem that any earlier device issues have been worked out by dexcom.
 
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Brand NameDEXCOM SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11093941
MDR Text Key224599011
Report NumberMW5098569
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/29/2020
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number7279759
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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: 12/29/2020 Patient Sequence Number: 1
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