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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
Model Number 9500-27
Device Problem Invalid Sensing (2293)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 02/15/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and seizures.
 
Event Description
Dexcom was made aware on 03/24/2017 that on (b)(6) 2017, the patient experienced continuous glucose monitoring (cgm) inaccuracies and a hypoglycemic event. Patient's mother reported that the continuous glucose monitor (cgm) did not alert. Patient had a seizure, hit his face on a coffee table, and received facial bruising. Patient's blood glucose (bg) was 45 mg/dl at the time of event. No separate glucose values were provided for comparison of cgm and finger stick bg. Patient was treated with a glucagon shot. Patient's mother call 911. Emergency medical technicians (emts) took patient to emergency room (er). Patient's bg was over 100 mg/dl at time of release from er. At time of contact, patient is fine. No additional event or patient information is available. No product or data was provided for investigation. The reported issue could not be confirmed. The root cause could not be determined.
 
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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 Key6507906
MDR Text Key73326471
Report Number3004753838-2017-26310
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 03/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
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 Received03/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/20/2017 Patient Sequence Number: 1
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