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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 Operating System Version or Upgrade Problem (2997)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/24/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that mobile app interruption due to os upgrade on smart device occurred.It was indicated that the operating system for the smart device was not a supported system, which is misuse of the device.Data was received but not investigated as data will not confirm the issue.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 Key10840933
Report Number3004753838-2020-136703
Device Sequence Number16884124
Product Code PQF
UDI-Device Identifier00386270000002
UDI-Public00386270000002
Combination Product (Y/N)N
Initial Reporter StateWA
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) 11/13/2020
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 NumberSW10611
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 10/24/2020
Initial Report FDA Received Date11/13/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age61 YR
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