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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 SW11786
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2022
Event Type  malfunction  
Event Description
It was reported that login was prompted during a sensor session.It was indicated that the patient was using an unsupported operating system, which is misuse of the device.Data was evaluated and the allegation was undetermined.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 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 Key14918489
MDR Text Key303070750
Report Number3004753838-2022-115995
Device Sequence Number1
Product Code QDK
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K182041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 07/05/2022
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 Catalogue NumberSW11786
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/08/2022
Initial Date FDA Received07/05/2022
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 Age72 YR
Patient SexMale
Patient Weight86 KG
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