MAUDE Adverse Event Report: DEXCOM, INC. T:SLIM G4 SYSTEM; OYC

Model Number 9500-27

Device Problem Invalid Sensing (2293)

Patient Problem Seizures (2063)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2016 that on (b)(6) 2016, that the patient experienced continuous glucose monitoring (cgm) inaccuracies and a seizure.The sensor was inserted at the abdomen on (b)(6) 2016.The patient reported that the cgm read 80mg/dl and the finger stick (fs) was 39 mg/dl.After taking the fs, patient experienced a seizure at her house.Patient's boyfriend gave patient a glucagon shot.Patient did not go to the hospital; patient stayed home and rested.At the time of contact, patient is okay.No additional event or patient information is available.No product or data was provided for evaluation.The customer complaint could not be confirmed.A root cause could not be determined.

• Brand Name: T:SLIM G4 SYSTEM
• Type of Device: OYC
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 6107369
• MDR Text Key: 60071158
• Report Number: 3004753838-2016-80872
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)NI(17)NI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 44