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

Model Number MT20649

Device Problem No Audible Alarm (1019)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and seizures.

Event Description

Patient contacted dexcom on (b)(6) 2016 to report that they experienced no audio output from the receiver and a hypoglycemic event on (b)(6) 2016.Patient had low blood sugar, 27mg/dl, because the receiver did not beep.The patient's wife found the patient having a seizure, and she called 911.Emergency medical services (ems) arrived and administered glucagon to the patient.Additionally, the patient tested the audio function of the receiver and it did not beep.No additional event or patient information was reported.

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 reported fault could not be reproduced and there was no failure detected.A review of the downloaded receiver log did not find any errors related to the customer complaint.A manual drop test for intermittency was performed and the test passed.The device was determined to be operating within the required specifications without malfunction.The reported event of no audio output was not confirmed.A 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: 5592650
• MDR Text Key: 43152474
• Report Number: 3004753838-2016-42702
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000064
• UDI-Public: (01)00386270000064(241)MT20649(10)5178455(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,Followup
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• 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: STR-GL-001
• Device Lot Number: 5178455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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: 76 YR
• Patient Weight: 81