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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
Catalog Number SW10611
Device Problem Defective Alarm (1014)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 10/07/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and seizure.
 
Event Description
Dexcom was made aware on 10/08/2016 that on (b)(6) 2016, the patient experienced a no audio alert from the smart device and an adverse event. Patient's mother reported that the patient experienced a seizure due to low blood sugar (bg). At the time of event, patient's mother stated the smart device display showed low with (2) arrows down. Patient mother treated patient with (1) one glucagon shot and called paramedics. Paramedic transported patient to hospital. Patient was admitted at 12:30 am and discharged at 12:30 pm. At the time of contact patient was doing well and recovering. No additional event or patient information is available. Data was provided for evaluation. The reported no audio alert was confirmed via data. The root cause was determined to be patient misuse/error. The smart device was placed on mute.
 
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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 Key6068123
MDR Text Key58813452
Report Number3004753838-2016-80636
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 10/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSW10611
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 Received10/08/2016
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: 10/31/2016 Patient Sequence Number: 1
Treatment
(B)(6)
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