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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
Catalog Number SW10497
Device Problem No Audible Alarm (1019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the receiver had intermittent audio alert on the mobile app. No data was provided for evaluation. Confirmation of the allegation and a probable cause could not be determined. No injury or medical intervention was reported.
 
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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 Key12519230
MDR Text Key273806118
Report Number3004753838-2021-165815
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSW10497
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/06/2021
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

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