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U.S. Department of Health and Human Services

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

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DEXCOM, INC. DEXCOM G5 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930); Cancer (3262)
Event Date 08/14/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known contributor to the development of infection.
 
Event Description
Dexcom was made aware on 08/17/2016 that the patient was hospitalized due to infection on (b)(6) 2016. Patient's friend reported that the patient's husband drove the patient to the hospital due to a high fever. Patient had gone through cancer treatment and experienced an infected port due to the treatments. At the time of contact, the patient was still in the hospital and receiving acetaminophen around the clock. Infection was not related to the dexcom continuous glucose monitor (cgm). There was no alleged device malfunction. No additional event or patient information was provided. No product or data was returned for investigation. The reported event could not be confirmed. A root cause could not be determined.
 
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Brand NameDEXCOM G5 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceCONTINUOUS GLUCOSE MONITOR
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key5937703
MDR Text Key54262683
Report Number3004753838-2016-80343
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 08/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/08/2016 Patient Sequence Number: 1
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