MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 GLUCOSE MOUNTING DEVICE; SENSOR, GLUCOSE, INVASIVE

Device Problem Incorrect Measurement (1383)

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

Event Date 08/29/2018

Event Type  Injury  

Event Description

Dexcom g6 glucose monitor measurement was two points low of 30% off of the actual reading checked using another meter.Actual reading was 36.The pt (my wife) was aware enough to fully recover.The measurement was done at waking.The g6 alarm was set at 70, and the reading from the g6 was just above that level.

• Brand Name: DEXCOM G6 GLUCOSE MOUNTING DEVICE
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 7842417
• MDR Text Key: 119259408
• Report Number: MW5079545
• Device Sequence Number: 1
• Product Code: MDS
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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 Outcome(s): Life Threatening; Other
• Patient Age: 71 YR
• Patient Weight: 59