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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM ONE CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM ONE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 9535-45
Device Problem Premature End-of-Life Indicator (1480)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that early sensor expiration occurred. Data was provided for evaluation. Per (b)(4), cases where the sensor session line is missing in share support tool and share support service, complaints will be closed since a data investigation cannot be completed as data ambiguity cannot be resolved further. Confirmation of the allegation and a probable cause could not be determined. No injury or medical intervention was reported.
 
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Brand NameDEXCOM ONE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS 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 Key12856472
MDR Text Key282265431
Report Number3004753838-2021-298964
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeBU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation
Type of Report Initial
Report Date 11/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9535-45
Device Catalogue NumberSTS-DO-003
Device Lot Number5294855
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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