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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 9438-06
Device Problem Wireless Communication Problem (3283)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, a loss of connection between the transmitter and smart device occurred. No additional patient or event information is available. Data was provided for evaluation. Data review confirmed the reported event of a loss of connection. A root cause could not be determined via data. The transmitter has been received for evaluation. An external visual inspection was performed and the transmitter passed. (b)(6) bluetooth device pairing test was performed and the transmitter passed. Global transmitter final functional test was performed and the transmitter passed as no failures were found related to the customer complaint. However, the share log data was reviewed and the logs confirm the patient complaint. The customer complaint of loss of connection was confirmed. The root 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 (Section G)
DEXCOM, INC.
6340 sequence dr.
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence dr.
san diego, CA 92121
8582000200
MDR Report Key6215804
MDR Text Key63660509
Report Number3004753838-2016-56218
Device Sequence Number1
Product Code MDS
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 12/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9438-06
Device Catalogue NumberSTT-GF-001
Device Lot Number5216377
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2016
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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