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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 SYSTEM
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DEXCOM, INC. DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Catalog Number SW11677
Device Problem Wireless Communication Problem (3283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that signal loss over one hour occurred.No product or data was provided for evaluation.The allegation and a probable cause could not be determined.No injury or medical intervention was reported.
 
Event Description
Subsequent to the initial mdr, a correction is required and additional information is available.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING 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 Key17554447
MDR Text Key321229374
Report Number3004753838-2023-161839
Device Sequence Number1
Product Code QDK
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberSW11677
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Age37 YR
Patient SexMale
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