MAUDE Adverse Event Report: DEXCOM INC DEXCOM G6 CGM; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

Model Number G6 CGM

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/14/2021

Event Type  malfunction  

Event Description

I am conducting a research study and using the dexcom g6 continuous glucose monitor in my study of pregnant women with and at risk for gdm.Four of the participants in our study experienced sensor deployment failures (i.E., the sensor did not come off of the applicator as it should have) during our study visits conducted via (b)(6).This unanticipated malfunction did not harm our participants, thankfully, but we believed the fda should know.(b)(4).We have reported these malfunctions to dexcom.We describe approx mean values for these 4 research participants in completing this form (weight, etc.), to protect their confidentiality.Therapy start date: (b)(6) 2021.Therapy end date: (b)(6) 2021.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 CGM
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): DEXCOM INC ; san diego
• MDR Report Key: 11595424
• MDR Text Key: 243576341
• Report Number: MW5100413
• Device Sequence Number: 1
• Product Code: QBJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2021
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/30/2021
• Device Model Number: G6 CGM
• Device Lot Number: 5278432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 77