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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
Model Number 9500-27
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 03/12/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The g5 system is associated with product code pqf. Diabetes mellitus is a known cause of hypoglycemia and seizures.
 
Event Description
Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, that the patient experienced an adverse event. Patient reported experiencing a hypoglycemic event while the continuous glucose monitor (cgm) was displaying "???". Patient's wife reported she woke up and noticed patient was convulsing. Patient's wife called paramedics. Prior to emergency medical services (ems) arriving, patient reported that he drank 12 ounces of soda. Paramedics arrived and took patient's finger stick (fs). The fs blood glucose (bg) value was 30 mg/dl, while the cgm displayed "???". Paramedics treated the patient with an unknown iv solution and instructed him to eat some protein. Paramedics stayed with patient approximately 1. 5 hours. Patient was not transported to hospital. At the time of contact, patient is well. No additional event or patient information is available the complaint states the patient experienced an error reading symbol on and an adverse event. Data was returned and evaluated. The reported error reading symbol event was confirmed via data. A root cause could not be determined.
 
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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 Key6476618
MDR Text Key72250595
Report Number3004753838-2017-26279
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00386270000019
UDI-Public(01)00386270000019(241)9500-27(10)5218534(17)170919
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 03/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/19/2017
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot Number5218534
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 Received03/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/10/2017 Patient Sequence Number: 1
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