• 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
Catalog Number STT-GF-004
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/05/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a pairing failure occurred.Data was evaluated and the allegation was confirmed.The probable cause was determined to be signal loss.In addition, the probable cause of the signal loss could not be determined.The reported event of a pairing failure is reportable based on the finding of the signal loss for over an hour.No injury or medical intervention was reported.
 
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
Manufacturer Contact
ashley spoto
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key12509498
MDR Text Key273678015
Report Number3004753838-2021-888888
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,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 Catalogue NumberSTT-GF-004
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/21/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-