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

Model Number MT22719

Device Problem No Audible Alarm (1019)

Patient Problem Seizures (2063)

Event Date 06/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2016 to report that they experienced no audio output from the receiver and an adverse event on (b)(6) 2016.The patient stated having a seizure due to her receiver not altering.A co-worker of the patient's called the paramedics.In addition, the nurse for the office was called down as well and the patient was given a glucagon shot with food to bring up her blood glucose (bg).The patient's bg values were at 32mg/dl before treatment was given and after the patient's bg was at 150mg/dl with the paramedics on site and checking.Patient was not transported to the hospital.At the time of contact, the patient was good.No additional event information was provided.

Manufacturer Narrative

(b)(4) if follow-up, what type?: additional information, correction/removal reporting number - additional.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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: 5767047
• MDR Text Key: 48710892
• Report Number: 3004753838-2016-38658
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000231
• UDI-Public: (01)00386270000231(241)MT22719(10)5205007(17)NI
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

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: MT22719
• Device Catalogue Number: STK-GF-001
• Device Lot Number: 5205007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2015
• 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: 58 YR
• Patient Weight: 101