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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 Imprecision (1307)
Patient Problems Hypoglycemia (1912); Seizures (2063); Vomiting (2144)
Event Date 09/24/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia.
 
Event Description
Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter and a hypoglycemic event. The sensor was inserted into the abdomen on (b)(6) 2017. The patient stated that they were eating ice cream and took insulin to cover the ice cream intake. The patient began to feel sick at 10:30 pm and began to vomit. The patient told her husband that her chest began to sting and hurt, and her hands began to sting and feel itchy. It was indicated that the cgm alarmed at 55 mg/dl; however, the patient tested her bg on her glucometer and it was 20 mg/dl. The patient's husband administered the patient with 1 glucagon pill and 2 mints. The patient began to have a seizure and at 10:45 pm, the patient's husband called the paramedics. When the paramedics arrived, they administered the patient with glucagon and an intravenous (iv) drip while the patient was being transported to the hospital. The patient was admitted to the hospital but could not recall what happened during her admittance. The patient was in the hospital overnight and was discharged at 4:30 am after she was stabilized. Additionally, the patient stated that due to the inaccurate values, she was not notified in advance regarding the low event. At the time of contact, the patient was in stable condition. No additional patient or event information is available. No data was provided for evaluation. The reported event of inaccuracies could not determined. A root cause could not be determined. It was reported that the patient did not calibrate after the inaccuracy. Dexcom labeling indicates: if the difference between your sensor glucose reading and blood glucose value is greater than 20% of the blood glucose value for sensor glucose readings > 80 mg/dl or greater than 20 points for sensor glucose readings < 80 mg/dl, wash your hands and take another blood glucose measurement. If the difference between this second blood glucose measurement and the sensor is still greater than 20% for sensor glucose readings > 80 mg/dl or greater than 20 points for sensor glucose readings < 80 mg/dl, recalibrate your sensor using the second blood glucose value. The sensor glucose reading will correct over the next 15 minutes.
 
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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 Key7004210
MDR Text Key91153280
Report Number3004753838-2017-97672
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 10/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2017
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
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/10/2017
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: 11/06/2017 Patient Sequence Number: 1
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