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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 MT20649-2
Device Problem No Audible Alarm (1019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the receiver had no audio output. No product or data was provided for evaluation. Confirmation of the allegation and a probable cause could not be determined. No injury or medical intervention was reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The product was evaluated. An external visual inspection was performed and passed. Receiver charge and boot tests were performed and passed. Functional tests were performed and passed. A "try it" test was performed and passed. An internal visual inspection was performed and passed. The audio speaker resistance was measured and passed. The receiver log was downloaded and reviewed finding no error related to the complaint. The allegation was not confirmed. The 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 dr.
san diego CA 92121
Manufacturer Contact
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key9764412
MDR Text Key181382986
Report Number3004753838-2020-019633
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 distributor,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649-2
Device Catalogue NumberSTR-GL-102
Device Lot Number5079115
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/29/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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