Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC.; CONTINUOUS GLUCOSE MONITOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEXCOM, INC.; CONTINUOUS GLUCOSE MONITOR Back to Search Results
Model Number 9438-06
Device Problem No Device Output (1435)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/23/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that transmitter failed error occurred.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.
 
Event Description
It was reported that transmitter failed error occurred.The product was evaluated.An external visual inspection was performed and passed.Exterior physical visual inspection was performed and passed.Voltage check was performed and passed.Pairing test/download was performed and passed.A review of the share logs was performed and transmitter failed error was not found within the investigation window.The allegation was not confirmed.The probable cause could not be determined.No injury or medical intervention was reported.
 
Manufacturer Narrative
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
CONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
MDR Report Key12297337
MDR Text Key267933176
Report Number3004753838-2021-138357
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number9438-06
Device Catalogue NumberSTT-GF-004
Device Lot Number5283455
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2021
Was the Report Sent to FDA? No
Date Manufacturer Received10/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-