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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9438-05
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/21/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2019 that the display device showed a transmitter failed error on (b)(6) 2019. No additional patient or event information is available. No product or data was provided for evaluation. The complaint confirmation of a transmitter failed error could not be determined. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a transmitter failed error occurred. The product was evaluated. An external visual inspection was performed and passed. Voltage testing was performed and resulted in 0 voltage. There was no data log available to confirm the reported event of a failed transmitter error. The complaint confirmation was unable to be determined. A probable cause could not be determined. No injury or medical intervention was reported.
 
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Brand NameDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
ying chen
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key8438680
MDR Text Key139743070
Report Number3004753838-2019-27817
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9438-05
Device Catalogue NumberSTT-GL-004
Device Lot Number5242558
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2018
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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