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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 9438-06
Device Problem Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the transmitter displayed an error message for low transmitter battery. Data was provided for evaluation. Data review could confirm the reported event of low transmitter battery. A probable cause is low transmitter battery voltage. This complaint is reportable based on the finding of transmitter failure. No product was provided for evaluation. No additional patient or event information is available.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint device was returned for evaluation. The device was visually inspected, and no defect was found. Voltage testing was performed, and the test failed. A review of the downloaded share log did not confirm the reported event of a low transmitter battery alert. The probable cause could not be determined. However, a failed transmitter error was found in connection to the reported allegation. The reported issue of a low transmitter battery alert is reportable based on the finding of a failed transmitter error. No additional patient or event 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 dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key7974657
MDR Text Key124575585
Report Number3004753838-2018-97077
Device Sequence Number1
Product Code MDS
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9438-06
Device Catalogue NumberSTT-MC-001
Device Lot Number7241010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2018
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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