MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 9500-27

Device Problems Imprecision (1307); Use of Device Problem (1670)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 10/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and seizures.

Event Description

Dexcom was made aware on (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 an adverse event.The sensor was inserted into the abdomen on (b)(6) 2017.The patient¿s husband stated that the patient had a seizure while she was sleeping due to having low bg values.The patient¿s husband treated the patient with juice and sugar and did not call 911.It was indicated that the patient recovered after being treated.Additionally, the patient stated a finger stick reading was not performed at the time of event; however, she only experienced seizures when her bg is in the 50¿s mg/dl.It was indicated that the cgm was displaying a value slightly above 100 mg/dl.At the time of contact, the patient was in stable condition.No additional patient or event information is available.No data was available for evaluation.The confirmation of inaccuracies could not be determined.A root cause could not be determined.Reportedly, the patient did not calibrate after the inaccuracy.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.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 7058189
• MDR Text Key: 92899850
• Report Number: 3004753838-2017-099357
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: 00386270000019
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/05/2018
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5226067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR