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

Model Number MT20649-BLU

Device Problem No Audible Alarm (1019)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia resulting in seizure.

Event Description

Patient's father contacted dexcom on 02/27/2016 to report an adverse event that occurred on (b)(6) 2016.Patient's father stated that the patient had a seizure due to critical low blood glucose and had to be given glucagon.Patient's receiver did not alert them to the low event.Patient's father tested the receiver and it did not beep.No additional event or patient information was provided.

• Brand Name: DEXCOM G4 PLATINUM 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: 5521893
• MDR Text Key: 41007713
• Report Number: 3004753838-2016-02077
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000095
• UDI-Public: (01)00386270000095(241)MT20649-BLU(10)5197249(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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/27/2016

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-BLU
• Device Catalogue Number: STK-GL-BLU
• Device Lot Number: 5197249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2016
• Initial Date FDA Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• 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: 35 YR
• Patient Weight: 78