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

Model Number MT20649-1

Device Problems Defective Alarm (1014); Device Operates Differently Than Expected (2913)

Patient Problems Fainting (1847); Hypoglycemia (1912); Seizures (2063)

Event Date 09/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and its associated effects.

Event Description

Dexcom was made aware on 10/12/2016, that on (b)(6) 2016, the patient experienced intermittent audio output from the receiver and an adverse event.During the night, the patient's family described not hearing any kind of alert and the patient fell into severe hypoglycemia.An ambulance and an emergency physician were called.The physician was able to stabilize the patient so that a transfer to the hospital was not necessary.Additionally, it was reported that during the event, the patient experienced fainting and an epileptic seizure.Additional event or patient information is not available.No product or data was provided for evaluation.The reported event of intermittent audio output was not confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced an adverse event.It was reported that during the night, the patient's family did not hear any kind of alert and the patient fell into severe hypoglycemia.An ambulance and an emergency physician were called.The physician was able to stabilize the patient so that a transfer to the hospital was not necessary.Additionally, it was reported that during the event, the patient experienced fainting and an epileptic seizure.Additional event or patient information is not available.No product or data was provided for evaluation.The reported event of intermittent audio output was not confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS 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 Key: 6088042
• MDR Text Key: 59450570
• Report Number: 3004753838-2016-70740
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-1
• Device Catalogue Number: STR-GL-004
• Device Lot Number: 5202335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3004753838-02/29/16-001C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR
• Patient Weight: 60