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

Lot Number 7280202

Device Problems Retraction Problem (1536); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 05/06/2021

Event Type  malfunction  

Event Description

Dexcom g6 sensor inserter needle was not retracted after insertion of the sensor, leaving the inserter stuck on the patient.I hit the insertion device with a wooden spoon and the needle retracted and came off the patient.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11831715
• MDR Text Key: 251364259
• Report Number: MW5101376
• 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: Patient
• Type of Report: Initial
• Report Date: 05/12/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/08/2021
• Device Lot Number: 7280202
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 50