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

Model Number MT22719

Device Problems Vibration (1674); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Patient's mother contacted dexcom on (b)(6) 2015 to report that on (b)(6) 2015 the patient's receiver was vibrating continuously.There was no report of any injury or medical intervention.No additional event or patient information is available.Complaint device was returned for evaluation.A visual exterior inspection was performed on the receiver and found no issue related to the customer complaint.A global receiver functional test was performed on the receiver and found no failures related to the customer complaint.Receiver's data logs were downloaded and reviewed, finding a screen error alarm on the date of issue, in addition to a firmware error.Opened the receiver case for visual an interior visual inspection and it passed.Based on the finding of a firmware error this is being reported.The complaint was confirmed.The root cause could not be determined post investigation.

Manufacturer Narrative

(b)(4).

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS 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: 5603894
• MDR Text Key: 44449607
• Report Number: 3004753838-2016-02671
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000231
• UDI-Public: (01)00386270000231(241)MT22719(10)5204953(17)NI
• 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: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• 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: STK-RF-001
• Device Lot Number: 5204953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2015
• 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: 14 YR