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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
Model Number 9445-02
Device Problem No Device Output (1435)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a transmitter failed error occurred. Data was evaluated and the allegation was confirmed. The probable cause could not be determined. No injury or medical intervention was reported.
 
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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 Key11102453
MDR Text Key225786582
Report Number3004753838-2020-167470
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9445-02
Device Catalogue NumberSTT-GS-003
Device Lot Number7274327
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2020
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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