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

Model Number MT22719

Device Problem No Audible Alarm (1019)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Seizures (2063)

Event Date 07/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) diabetes mellitus is a known cause of hypoglycemia, hyperglycemia and diabetes induced seizures.

Event Description

Dexcom was made aware on 08/18/2016, that on (b)(6) 2016, the patient experienced no audio output from the receiver and an adverse event.The patient reported that the dexcom receiver malfunctioned and the speaker doesn't notify them when blood glucose levels are low or high.Patient stated it is particularly alarming when they are low because they are slightly dependent on the device to notify them when a low or high event occurs.Several seizures have occurred because of the reported defect.Patient further reported that they were still waiting for their receiver to come in the mail and it was going on week 2.Patient felt vulnerable, especially when their sugars were low, because they have become accustomed to the alerts when their sugar drops.No additional event or patient information was provided.No product or data was provided for investigation.The reported event of no audio output could not be confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).Voluntary medwatch report # mw5063829.

• 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: 5953378
• MDR Text Key: 54835930
• Report Number: 3004753838-2016-80431
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000231
• UDI-Public: (01)00386270000231(241)MT22719(10)NI(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: other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/18/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention