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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 09/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, patient experienced a failed transmitter error. No additional patient or event information is available. No product or data were provided for evaluation. The complaint confirmation of a failed transmitter could not be determined. A root cause could not be determined.
 
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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 (Section G)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key7975785
MDR Text Key124376779
Report Number3004753838-2018-125118
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeNL
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
Report Date 09/19/2018
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 Number9438-05
Device Catalogue NumberSTT-GL-004
Device Lot Number5234851
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2018
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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