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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 N/A
Medical Device Problem Code Wireless Communication Problem (3283)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/24/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that signal loss over one hour occurred.It was determined that loss of connection was related to the mobile application.Data was received for evaluation.However, the alleged product is not present within the investigation window.Confirmation of the allegation and a probable cause could not be determined.No injury or medical intervention was reported.
 
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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 Key10393473
Report Number3004753838-2020-086504
Device Sequence Number11667481
Product Code PQF
UDI-Device Identifier00386270000293
UDI-Public00386270000293
Combination Product (Y/N)N
Initial Reporter StateAZ
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) 08/11/2020
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 NumberN/A
Device Catalogue NumberSW10940
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 07/24/2020
Initial Report FDA Received Date08/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age31 YR
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