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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM FOLLOW APP CONTINUOUS GLUCOSE MONITOR

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DEXCOM, INC. DEXCOM FOLLOW APP CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Hypoglycemia (1912)
Event Date 01/17/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia. Voluntary medwatch report number mw-5092455.
 
Event Description
It was reported that the patient experienced a hypoglycemic event. The patient¿s caregiver stated they were not able to view data on the follow app which resulted in the patient missing a hypoglycemic event. They stated that they were able to identify, reverse and stabilize the event before a serious injury occurred. No data or product was provided for investigation. Confirmation of the allegation was undetermined. The probable cause could not be determined. No product was provided for evaluation.
 
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Brand NameDEXCOM FOLLOW APP
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key9775566
MDR Text Key181756806
Report Number3004753838-2020-020347
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberSW10583
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/02/2020 Patient Sequence Number: 1
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