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 MT20649-3
Device Problem Failure to Calibrate (2440)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/15/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that there were no calibration prompts.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 there were no calibration prompts.The product was evaluated.An external visual inspection was performed and passed.Charge and boot test was performed and passed.Receiver functional test was performed and passed.Receiver manual alerts test was performed and passed.A review of the receiver logs was performed and the second manual blood glucose calibration was found in the receiver logs 12 hours after the initial calibration on incident date (b)(6) 2020.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 Key10340248
MDR Text Key202166413
Report Number3004753838-2020-079352
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 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMT20649-3
Device Catalogue NumberSTK-JP-019
Device Lot Number5253169
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/15/2020
Initial Date FDA Received07/29/2020
Supplement Dates Manufacturer Received10/12/2020
Supplement Dates FDA Received10/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age118 YR
-
-