MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number MT22495-BLU

Device Problem Defective Alarm (1014)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 09/19/2016

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)(6) 2016, that on (b)(6) 2016, the patient experienced intermittent vibration from the receiver and an adverse event.The patient reported that his wife called the ambulance due to his low blood sugar and to him seizing.The receiver did not alert the patient during the low event.The ambulance arrived on the site and the medical staff tested the patient's blood glucose with a fingerstick, which read 60mg/dl.The patient was given glucose via an iv, in the ambulance, on the way to the hospital.The patient was rushed to the emergency room (er) at 4:00am and was discharged at 8:30am.At the time of contact, the patient was stable.No additional event or patient information is available.No product or data was returned for evaluation.The reported event of intermittent vibration could not be confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The complaint device was returned for evaluation.The device was visually inspected and no defect was found.Functional testing was performed and the and there was no failure detected.A review of the downloaded receiver log did not find any errors related to the customer complaint.The reported event of a an intermittent vibration was not confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE 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: 6042630
• MDR Text Key: 57915237
• Report Number: 3004753838-2016-80588
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000170
• UDI-Public: (01)00386270000170(241)MT22495-BLU(10)5202033(17)NA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495-BLU
• Device Catalogue Number: STK-DR-BLU
• Device Lot Number: 5202033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2015
• Is the Device Single Use?: No
• 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: 50 YR
• Patient Weight: 118