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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC.; CONTINUOUS GLUCOSE MONITOR

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DEXCOM, INC.; CONTINUOUS GLUCOSE MONITOR Back to Search Results
Catalog Number STK-GF-013
Device Problem No Audible Alarm (1019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the receiver had no audio output.No product or data was provided for evaluation.Confirmation of the allegation and a probable cause could not be determined.No injury or medical intervention was reported.
 
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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 Key12505817
MDR Text Key273558408
Report Number3004753838-2021-163831
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 09/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/07/2022
Device Catalogue NumberSTK-GF-013
Device Lot Number5286502
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2021
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 Age42 YR
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