MAUDE Adverse Event Report: DEXCOM, INC. INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED; SENSOR, GLUCOSE, INVASIVE

Model Number G6

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Event Description

Patient called to report the issues he is having with the dexcom g6 glucose monitor.He says the monitor loses connection for 3 to 4 hours randomly for no good reason.He also said he gets false low reading while he is sleeping.He said sometimes he gets a reading as low as 60 mg/dl and when he measures it on a different device, it reads 115 mg/dl.He thinks that is a wide range for a false reading.He said sometimes he treats it and sometimes it corrects itself.He said he contacted the manufacturer but all they do is send him a different one.He said most of them have similar problems and having another one did not help.

• Brand Name: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12217643
• MDR Text Key: 263425677
• Report Number: MW5102739
• Device Sequence Number: 2
• 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: 07/22/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G6
• Device Lot Number: 7282178
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 108