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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9500-27
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of consciousness (2418)
Event Date 11/30/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). This mdr is to capture two of the two unspecified severe reactions that was reported.
 
Event Description
It was documented in a social media post that the patient reported a signal loss and two severe reactions occurred. The patient's husband found her unresponsive and administered two glucagon injections. Information about the two severe reactions and the continuous glucose monitor (cgm) or blood glucose (bg) values was not provided. Neither the patient nor her husband received an alert that there was an issue with the patient's blood glucose or that the follow application was not working. No product or data was provided for investigation. Problem could not be confirmed, and probable cause could not be determined. Per medical review, this report would constitute an adverse event because an allegation against the dexcom system resulted in a hypoglycemic event that required treatment with glucagon. No additional event or patient information is available.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
ashley spoto
6340 sequence drive
san diego, CA 92121
8582036280
MDR Report Key9517106
MDR Text Key172695507
Report Number3004753838-2019-112147
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public00386270000019
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 12/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/24/2019 Patient Sequence Number: 1
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