MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS

Model Number 9438-06

Device Problem Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2015, to report that on (b)(6) 2015, the g5 transmitter could not be found on the g5 application.No additional event or patient information is available.The device has been received.Investigation is not yet complete.A follow-up will be submitted upon completion of device analysis.

Manufacturer Narrative

(b)(4).

Event Description

The complaint device was returned for evaluation.The device was visually inspected and no defect was found.Sensor voltage was measured and failed.The transmitter was tested on a transmitter tester and was unable to connect resulting in failure.The customer complaint was confirmed.The root cause was determined to be a defective transmitter.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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: 5299804
• MDR Text Key: 34122195
• Report Number: 3004753838-2015-82491
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000224
• UDI-Public: 00386270000224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• 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: 11/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9438-06
• Device Catalogue Number: STT-GF-001
• Device Lot Number: 5206822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2015
• 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: 25 YR