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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 Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a pairing failure occurred.Data was evaluated and the allegation was confirmed.The probable cause was determined to be signal loss.In addition, the probable cause of the signal loss was determined to be that the transmitter and app were unable to establish a connection.The reported event of a pairing failure is reportable based on the finding of the signal loss over one hour.No injury or medical intervention was reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
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 failed.A review of the share logs was performed and a pairing failure was found within the investigation window.The allegation was confirmed.The probable cause was determined to be signal loss.In addition, the probable cause of the signal loss was determined to be a defective transmitter.
 
Event Description
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 failed.A review of the share logs was performed and a pairing failure was found within the investigation window.The allegation was confirmed.The probable cause was determined to be signal loss.In addition, the probable cause of the signal loss was determined to be a defective transmitter.
 
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 Key15771900
MDR Text Key307074862
Report Number3004753838-2022-210018
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,Followup,Followup
Report Date 12/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/26/2023
Device Model Number9445-24
Device Catalogue NumberSTT-OR-001
Device Lot NumberP13507648
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received11/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2022
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 Age60 YR
Patient SexMale
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