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

Model Number STS-OR

Device Problems Break (1069); Entrapment of Device (1212); Obstruction of Flow (2423); Communication or Transmission Problem (2896); Connection Problem (2900); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Implant Pain (4561)

Event Date 07/18/2021

Event Type  Injury  

Event Description

Was inserting a dexcom g6 cgm into my right abdomen.[lot#: 5291584 ref#: (b)(4)] the applicator produced the distinguishable click sound as the insertion needle is plunged into the skin and produced the secondary click that indicates the insertion needle has been retracted and the applicator can be removed.However, the insertion caused me intense pain and throughout the night i would experience pain if any pressure were placed on the site.The transmitter failed to connect over night.Upon removal the following morning i discovered the insertion needle had been detached from the applicator and has been left inside me over night.The insertion needle was also causing the catheter that transports the blood to the transmitter to be blocked and occluded causing a pairing failure to the new transmitter.This batch of sensor applicators was sent to me by dexcom customer support advised as "a remanufactured lot of applicators" to fix a previous issue of the insertion device and insertion needle mechanically binding during insertion causing a failure in the release mechanism of the hand held inserter as well as a failure in the insertion needle retraction mechanism.The sensor of issue in this report was a replacement lot for a preexisting issue, only to cause an even worse issue of leaving an exposed needle inside the patient until they remove the site due to the insertion needle breaking from the inserter during insertion.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12203474
• MDR Text Key: 262994013
• Report Number: MW5102668
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 40386270000253
• UDI-Public: (01)40386270000253
• 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: 07/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/05/2022
• Device Model Number: STS-OR
• Device Lot Number: 5291584
• 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; Disability
• Patient Age: 22 YR
• Patient Weight: 95