MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G-6 CGM; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hypoglycemia (1912)

Event Date 05/04/2020

Event Type  malfunction  

Event Description

Hypoglycemia; dexcom g-6 meter stopped working, i'm a brittle type 1 diabetic.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G-6 CGM
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10038210
• MDR Text Key: 190507707
• Report Number: MW5094410
• Device Sequence Number: 1
• Product Code: QDK
• Combination Product (y/n): N
• 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: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 83