MAUDE Adverse Event Report: DEXCOM G5 CGM

Model Number MT22719

Device Problems Incorrect Or Inadequate Test Results (2456); Connection Problem (2900); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2016

Event Type  Injury  

Event Description

I switched from dexcom's g4 cgm to the g5 model in (b)(6) of this year and have had many serious problems including: repeated failures to connect over bluetooth with my smart phone; a frequent large difference between the cgm's reading and what i get from a finger stick using my onetouch glucometer, and a complete failure of the g5 receiver unit.The g4 unit worked quite well, maintaining a signal between the transmitter and receiver consistently and reporting numbers which were always very close to what i obtained as readings from my onetouch meter.I have talked at great length with dexcom's customer support though it has generally involved long, long periods on hold, to not real effect.Many of their support staff have appeared to have minimal understanding of their own product.I have asked repeatedly to be contacted by someone higher up in order to either talk with someone who has greater knowledge of the product or to go back to the g4.Each time i have been told that someone will contact me either later that day or the following day, but it has never actually happened.At one point, dexcom did send me a new receiver and transmitter (the receiver had completely failed), but the new receiver / transmitter still will not connect most of the time and the readings still sometimes have differences of approx 25 - 35 mg/dl vs the onetouch readings.As i'm sure you know, the result of this can be hypo or hyperglycemic episodes which may cause anything from altered level of consciousness to coma or death.If, for example, aloc due to hypoglycemia occurs while operating a motor vehicle, the threshold for disaster can be fairly low.I gather from my physician and from diabetes focused online forums that my case is not at all unusual for users of the g5.It appears to be a product which was not ready for the market yet dexcom seems to have no interest in addressing the problem, which seem highly irresponsible.

• Brand Name: G5 CGM
• Type of Device: G5 CGM
• Manufacturer (Section D): DEXCOM
• MDR Report Key: 5924451
• MDR Text Key: 54029289
• Report Number: MW5064492
• Device Sequence Number: 1
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/30/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2017
• Device Model Number: MT22719
• Device Lot Number: LBL-010765 REV 05
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 66