MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS MONITORING SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number MT20649

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the receiver display screen turned white.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, finding no observations related to the customers complaint.A global functional test was performed on the receiver, finding no failures related to the customer complaint.The receiver data logs were downloaded and reviewed finding a screen error alarm, in addition to a hardware error.Based on the finding of a screen error this is being reported.The complaint was confirmed.The root cause was determined to be a ui-u1 board failure.

• Brand Name: DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS 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: 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 5959378
• MDR Text Key: 55003732
• Report Number: 3004753838-2016-84039
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000064
• UDI-Public: (01)00386270000064(241)MT20649(10)5196152(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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649
• Device Catalogue Number: STK-PU-001
• Device Lot Number: 5196152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2014
• 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