DEXCOM G6 CONTINUOUS MONITOR G6 - DEXCOM FOLLOW APP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-09 for DEXCOM G6 CONTINUOUS MONITOR G6 - DEXCOM FOLLOW APP manufactured by Dexcom, Inc..

Event Text Entries

[141799920] My daughter is on the dexcom g6. I use the dexcom "follow" app to be able to see her blood sugar level and more importantly, receive audible alerts when her blood sugar is in a dangerous range. Her blood sugar dropped to 48 and i did not receive an "audible alert". Fortunately i had decided to check her blood sugar with her meter prior to going to bed. I intervened by giving her glucose, thus saving her life. The problem is that dexcom has not upgraded its follow app to be compatible with (b)(6) operating system "9" or "(b)(6)" on mobile phones. Dexcom has been aware of this problem for over 6 months now and has yet to resolve the problem. Part of the problem is that mobile phones need to be updated from time to time. The most current upgrade automatically upgrades most phone to be "(b)(6)" operating system. Parents, pts and followers aren't aware that dexcom will not work with (b)(6) unit they are suddenly not receiving audible alerts. Also, if you need to buy a new mobile phone, new phones always require an operating system update when first turned on. The operating system that is installed on the phone is (b)(6) on new phones as it is the most current operating system on the market. This is a problem for anyone using the dexcom follow app that either has an operating system update or needs to buy a new phone. Again, dexcom has been aware of this problem for over 6 months yet they've yet to resolve it. The lack of proper audible alerts on dexcom follow app can result in death of the person wearing the dexcom as their followers are not alerted of their medical emergency. This is particularly true in young children that rely on their parents using the dexcom follow app to keep them alive. I'm asking the fda to please do something so that dexcom remedies this problem before someone dies. Six months is long enough for their programmers to resolve the problem. My daughter's glucose meter confirmed that her blood sugar/blood glucose had dropped to 48. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5085724
• MDR Report Key: 8500097
• Date Received: 2019-04-09
• Date of Report: 2019-04-05
• Date of Event: 2019-03-28
• Date Added to Maude: 2019-04-10
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: DEXCOM G6 CONTINUOUS MONITOR
• Generic Name: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MGMT
• Product Code: QDK
• Date Received: 2019-04-09
• Model Number: G6 - DEXCOM FOLLOW APP
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEXCOM, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2019-04-09