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

Model Number MT20649

Device Problem No Audible Alarm (1019)

Patient Problem Seizures (2063)

Event Date 05/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2016 to report that they experienced intermittent audio output from the receiver and an adverse event on (b)(6) 2016.The patient stated that she did not hear low alert and went into a diabetic seizure.The patient called and had ambulance come pick her up.The paramedics administered glucagon.When the patient arrived at emergency room she was given an iv with glucose and food.At the time of contact, the patient was doing well.Additionally, the patient tested the receiver's high alert and it sounded.No further event information was provided.Complaint device was returned for evaluation.A visual exterior inspection was performed on the receiver and found no observations related to the customer complaint.Data was downloaded from the receiver and reviewed, this resulted in no failures related to customer complaint.A global receiver functional test was performed on the receiver and it resulted in no failures related to customer complaint.The reported fault of intermittent audio output could not be reproduced.The complaint of intermittent audio output could not be confirmed.The root cause could not be determined.

• 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: 5800076
• MDR Text Key: 49736854
• Report Number: 3004753838-2016-38681
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000064
• UDI-Public: (01)00386270000064(241)MT20649(10)5196088(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
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649
• Device Catalogue Number: STK-GL-001
• Device Lot Number: 5196088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2014
• 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: 49 YR
• Patient Weight: 54