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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-BLU
Medical Device Problem Code Wireless Communication Problem (3283)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/08/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
Dexcom was made aware on (b)(4) 2017 that on (b)(6) 2017, patient experienced a loss of connection between the transmitter and receiver.No additional patient or event information is available.No product or data were provided for evaluation.The reported loss of connection could not be confirmed.A root cause could not be determined.
 
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Brand Name
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Common Device Name
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
MDR Report Key6834141
Report Number3004753838-2017-65736
Device Sequence Number13469120
Product Code MDS
UDI-Device Identifier30386270000096
UDI-Public30386270000096
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
P120005
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model NumberMT20649-BLU
Device Catalogue NumberSTR-GL-BLU
Device Lot Number5166457
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/09/2017
Initial Report FDA Received Date08/31/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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