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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

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DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abscess (1690)
Event Date 01/09/2017
Event Type  Death  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known risk factor for developing peritonsillar abscess.
 
Event Description
Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the patient was hospitalized and then later passed away on (b)(6) 2017. Patient's wife reported that the cause of death was caused by an abscess in the throat that prevented patient from eating. Patient's wife reported that the patient had been diagnosed with abscess. Patient was hospitalized for five (5) days. Patient was treated with antibiotics. Patient was then taken to a hospice for "a couple of days," then taken home. Patient's wife reported that the patient was under 24-hour care at home. Patient's wife called paramedics because the patient was not eating for a "few days. " patient was transported to hospital. Patient was treated by with antibiotics, then returned home "in a few days. " the name of the antibiotics and dates of hospitalization are unknown. It's not known where patient passed away. Patient was wearing the continuous glucose monitor (cgm) at the time of death. There was no alleged device malfunction. No additional event or patient information is available. No product or data was returned for evaluation. A certificate of death was not provided. The reported event of death could not be confirmed. A root cause could not be verified.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The receiver (part number stk-gl-001/serial number (b)(4)/lot number 5190868) being used at the time of event of returned for evaluation. A visual inspection was performed and no defects were found. Funcational testing was performed and no failures were detected. A review of the downloaded data log did not find any errors. Additionally, the transmitter (part number stt-gl-003/serial number (b)(4)/lot number 5210724) was also returned for evaluation. A visual inspection was performed and no defects were found. Functional testing was performed and no failures were detected. Voltage testing was performed and the transmitter has voltage. The devices were determined to be operating within the required specifications without malfunction. There was no alleged malfunction to the return devices.
 
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Brand NameDEXCOM G4 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 Key6358312
MDR Text Key68303475
Report Number3004753838-2017-10962
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2017
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 Received03/09/2017
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

Patient Treatment Data
Date Received: 02/24/2017 Patient Sequence Number: 1
Treatment
ANTIBIOTICS, UNKNOWN; STEROIDS, UNKNOWN
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