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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number MT22719
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/24/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, the receiver initialized without a manual restart. No additional event or patient information is available. The receiver was returned for evaluation. An external visual inspection was performed and passed. A receiver charge and boot was performed and failed due to unit perpetually rebooting. A receiver download was performed and passed. An internal visual inspection was performed and passed. Confirmation of the complaint was not confirmed. The probable cause could not be determined.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key7889587
MDR Text Key121567574
Report Number3004753838-2018-109829
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000613
UDI-Public00386270000613
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 08/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMT22719
Device Catalogue NumberSTR-MC-001
Device Lot Number5238460
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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