MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITOR; SENSOR, GLUCOSE, INVASIVE

Model Number 5917

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888)

Event Date 09/02/2021

Event Type  Injury  

Event Description

I was using a g6 dexcom.Continuous glucose monitor which is bluetooth connected to my insulin pump in a closed loop system.This was reading incorrectly and could have given me more insulin than i needed.This is not the first time this has happened.Faulty readings and failed sensors are traumatizing as well.It also bled really badly and i am now bruised pretty badly from it as well.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12446886
• MDR Text Key: 270914654
• Report Number: MW5103799
• 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: 09/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/19/2022
• Device Model Number: 5917
• Device Lot Number: 7286601
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 36 YR
• Patient Weight: 61