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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 SW11588
Device Problem Wireless Communication Problem (3283)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that signal loss over one hour occurred.It was determined that the signal loss was related to the mobile application.A review of the share logs was performed and signal loss was found within the investigation window.The allegation was confirmed.The probable cause was the transmitter and app were unable to establish a connection.No injury or medical intervention was reported.
 
Manufacturer Narrative
(b)(4).B5: describe event or problem - additional.D4: additional device information - correction.G6: follow-up number - additional.H2: if follow-up, what type - additional.
 
Event Description
It was reported that signal loss over one hour occurred.It was determined that the signal loss was related to the mobile application.A review of the share logs was performed and signal loss was found within the investigation window.The allegation was confirmed.The probable cause was the transmitter and app were unable to establish a connection.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
MDR Report Key12573631
MDR Text Key276468849
Report Number3004753838-2021-180717
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 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberSW11588
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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