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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT20649
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/18/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018 the receiver initialized without a manual restart. No additional event or patient information is available. No product or data were provided for evaluation. The report of the receiver initializing without manual restart could not be determined. A root cause could not be determined.
 
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Brand NameDEXCOM G4 PLATINUM PROFESSIONAL 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
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key7875421
MDR Text Key120268126
Report Number3004753838-2018-105299
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 other
Reporter Occupation
Type of Report Initial
Report Date 08/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT20649
Device Catalogue NumberSTK-PU-001
Device Lot Number5176534
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2014
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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