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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT22719-PNK
Medical Device Problem Code Wireless Communication Problem (3283)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/07/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).The patient experienced adverse events on different days with the same device.The following reports are being submitted: (b)(4).
 
Event or Problem Description
Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, a loss of connection between the transmitter and receiver occurred.No additional patient or event information is available.Data was received but does not reflect the full investigation window.The complaint confirmation of a loss of connection could not be determined.A root cause could not be determined.
 
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Brand Name
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Common Device Name
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
MDR Report Key7198266
Report Number3004753838-2018-06241
Device Sequence Number11262918
Product Code PQF
UDI-Device Identifier30386270000263
UDI-Public30386270000263
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
P120005
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/19/2017
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 NumberMT22719-PNK
Device Catalogue NumberSTK-GF-PNK
Device Lot Number5220935
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 12/19/2017
Initial Report FDA Received Date01/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age6 YR
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