MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

Model Number MT22495-PNK

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the receiver had no display except the backlight.No additional event or patient information is available.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 related to the complaint.The receiver log was reviewed and firmware errors and screen error alerts were observed.The reported event of no receiver display except backlight was confirmed during log review.A root cause could not be determined.Based on the investigation results this issue has been upgraded from non-reportable to reportable.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE 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: 6718601
• MDR Text Key: 80264747
• Report Number: 3004753838-2017-57781
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 30386270000164
• UDI-Public: (01)30386270000164(241)STR-DR-PNK(10)5219495
• 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
• Report Date: 05/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495-PNK
• Device Catalogue Number: STR-DR-PNK
• Device Lot Number: 5219495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2016
• 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: 59 YR