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

Catalog Number 9300-45

Device Problems Break (1069); Difficult to Remove (1528); Material Integrity Problem (2978); Mechanical Jam (2983)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 02/03/2020

Event Type  malfunction  

Event Description

My husband was replacing his dexcom g6 sensor pn 9500-45, lot 7266736 last night when the applicator device became stuck and would not release the sensor.He ended up having to yank the thing off his abdomen.He felt a piece broke off in his abdominal wall and felt there was a foreign body left.He called the dexcom hotline to report this and his diabetic nurse recommended he see a doctor.Today he went to the hospital and spent an hour in general surgery where he says they cut out a bunch of fat but couldn¿t find anything.He is now left with an abdominal wound.Open wounds/foreign bodies have a higher risk of infection diabetics, not to mention the whole thing was painful for him, this is quite disappointing.He tells me he noticed some issues with the dexcom of late, that he had a few sensors that worked incorrectly.He was wondering if the manufacturer had changed of late as he says they worked fine before.I have pictures of the dexcom unit and the wound before and after minor surgery if the fda would like them.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 9681669
• MDR Text Key: 178349246
• Report Number: MW5092824
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/12/2020
• Device Catalogue Number: 9300-45
• Device Lot Number: 7266736
• 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): Other
• Patient Age: 41 YR