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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 CGM INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

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DEXCOM, INC. DEXCOM G5 CGM INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED Back to Search Results
Device Problem Battery Problem (2885)
Patient Problem Hypoglycemia (1912)
Event Date 01/13/2019
Event Type  Injury  
Event Description
Dexcom g5 transmitter battery failed. While sleeping, adversely low blood sugar, hypoglycemia occurred.
 
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Brand NameDEXCOM G5 CGM
Type of DeviceINTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key8260824
MDR Text Key133831937
Report NumberMW5083219
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/02/2019
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

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