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

Model Number MT20649

Device Problem Loss of Data (2903)

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

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device was not returned for evaluation.The receiver data log was provided.The data log was reviewed and could not confirm the reported event as all data for seven days had been recorded.A root cause for the reported event cannot be determined.

Event Description

Clinical diabetes educator contacted dexcom technical support on behalf of the trial patient on (b)(6) 2015, to report that on (b)(6) 2015, the patient's receiver stopped capturing data for three days.No additional event or patient information is available.

• Brand Name: DEXCOM G4 PLATINUM PROFESSIONAL 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: 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 5035372
• MDR Text Key: 25047005
• Report Number: 3004753838-2015-80775
• Device Sequence Number: 1
• Product Code: MDS
• 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: study
• Reporter Occupation: Other
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• 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: 5188586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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