MAUDE Adverse Event Report: DEXCOM, INC. T:SLIM G4 SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number 9438-05

Device Problem Wireless Communication Problem (3283)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on 10/18/2016, that on (b)(6) 2016, the device had an intermittent out of range signal.No additional event or patient information is available.

Manufacturer Narrative

(b)(4).

Event Description

The complaint device was returned for evaluation.The device was visually inspected and no defect was found.Functional testing was performed and there was no failure detected.The reported event of an intermittent out of range was not confirmed.A root cause could not be determined.

• Brand Name: T:SLIM G4 SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• 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: 6087933
• MDR Text Key: 59464354
• Report Number: 3004753838-2016-23086
• Device Sequence Number: 1
• Product Code: OIC
• UDI-Device Identifier: 00386270000125
• UDI-Public: (01)00386270000125(241)9438-05(10)5212013(17)NA
• 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,Followup
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9438-05
• Device Catalogue Number: STT-GL-003
• Device Lot Number: 5212013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 116