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

Model Number MT22719

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the receiver displayed an error 121.No additional patient or event information is available.No product or data were returned for evaluation.The complaint could not be confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The complaint receiver was returned for evaluation.The device was visually inspected and no defect was found.The receiver log was reviewed firmware errors were observed.The reported event of an error icon display was confirmed during log review.A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING 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: 6215738
• MDR Text Key: 63656437
• Report Number: 3004753838-2016-63643
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000231
• UDI-Public: (01)00386270000231(241)MT22719(10)5215906(17)NA
• 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: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22719
• Device Catalogue Number: STR-GF-001
• Device Lot Number: 5215906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2015
• 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: 23 YR