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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Tachycardia (2095); Urinary Tract Infection (2120)
Event Date 07/29/2016
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
Dexcom was made aware on 08/08/2016 that the patient passed away on (b)(6) 2016. On the night of friday (b)(6) 2016, the patient woke with severe vomiting. After sometime, the patient recalled a similar feeling and instructed her husband to call 911. Emergency medical technicians (emts) were dispatched early saturday morning, (b)(6) 2016. Emts took the patient's blood pressure and blood glucose and rushed her to the medical center. When the patient arrived they were tachypnea and tachycardia with hypotension. The patient was given cat-scan and mri to evaluate obstruction however, the patient never became stable enough for treatment and died at approximately 3:05am (b)(6) 2016. The cause of death was reported as pyelonephritis. A certificate of death was not provided. Patient was not wearing the continuous glucose monitor (cgm) at the time of death, as it had been removed while in the hospital on (b)(6) 2016. There was no alleged device malfunction. Additional event or patient information was not provided. No product or data was returned for investigation. A certificate of death was not provided. The reported event could not be confirmed. A root cause could not be determined.
 
Manufacturer Narrative
(b)(4).
 
Event Description
A receiver (serial number (b)(4)/lot number 5213258) was returned for evaluation. Functional testing was performed and no failures were detected. A review of the downloaded data log did not find any errors. Additionally, a transmitter (serial number (b)(4)/lot number 5212248) was returned for evaluation. Functional testing and a pairing test was performed and the tests passed. Both the receiver and transmitter were determined to be operating within the required specifications without malfunction. There was no alleged malfunctions reported on the devices that were returned.
 
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Brand NameDEXCOM G5 MOBILE 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 Key5926720
MDR Text Key53893685
Report Number3004753838-2016-80174
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 08/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2016
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 Received10/03/2016
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: 09/02/2016 Patient Sequence Number: 1
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