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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM

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DEXCOM, INC. DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM Back to Search Results
Model Number 9445-24
Device Problem Wireless Communication Problem (3283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2023
Event Type  malfunction  
Event Description
It was reported that signal loss over one hour occurred.A review of the share logs was performed and a loss of connection was not found within the investigation window.The allegation was not confirmed.The probable cause could not be determined.No injury or medical intervention was reported.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM
Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key17199768
MDR Text Key317991937
Report Number3004753838-2023-126119
Device Sequence Number1
Product Code QDK
UDI-Device Identifier00386270001627
UDI-Public00386270001627
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
DEN170088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 06/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/19/2023
Device Model Number9445-24
Device Catalogue NumberSTT-OE-002
Device Lot NumberP15069082
Was Device Available for Evaluation? No
Date Manufacturer Received06/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/08/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age70 YR
Patient SexMale
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