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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 UNKNOWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/06/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the transmitter was having issues. No product or data were provided for evaluation. The confirmation of the complaint is undetermined. A probable cause could not be determined. No additional event or patient information is available.
 
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Brand NameNI
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 Key7937002
MDR Text Key123212841
Report Number3004753838-2018-118887
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 09/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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