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U.S. Department of Health and Human Services

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

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DEXCOM, INC. CONTINUOUS GLUCOSE MONITOR Back to Search Results
Catalog Number SW11677
Device Problem No Audible Alarm (1019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/09/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2019, that on (b)(6) 2019, no audio on app occurred. Data was provided for evaluation. The reported issue was not confirmed. The probable cause could not be determined. No additional event or patient information is available.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Subsequent to the initial mdr, a correction is required.
 
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Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key8388744
MDR Text Key138231582
Report Number3004753838-2019-023165
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 02/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSW11677
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 Received02/09/2019
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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