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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 01/25/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that signal loss over one hour occurred.The product was evaluated.An external visual inspection was performed and passed.Voltage test was performed and passed.Nordic bluetooth pairing test was performed and passed.A review of the bin file was performed and signal loss 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.
 
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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 Key16425129
MDR Text Key310054116
Report Number3004753838-2023-041913
Device Sequence Number1
Product Code QDK
UDI-Device Identifier00386270000651
UDI-Public00386270000651
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K203089
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 02/22/2023
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
Device Operator Lay User/Patient
Device Expiration Date09/06/2023
Device Model Number9445-24
Device Catalogue NumberSTT-OR-001
Device Lot NumberP14728577
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2023
Initial Date Manufacturer Received 01/25/2023
Initial Date FDA Received02/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/03/2022
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 Age51 YR
Patient SexFemale
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