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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 01/19/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that early sensor expiration occurred. The sensor was inserted into the arm on (b)(6) 2022. Data was evaluated and the allegation was not confirmed. The 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 Key13359074
MDR Text Key286639968
Report Number3004753838-2022-014771
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeLG
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation
Type of Report Initial
Report Date 01/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2022
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 Number5295292
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2021
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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