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

Model Number MT20649

Device Problem Circuit Failure (1089)

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

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for evaluation.A follow-up report will be submitted once the evaluation is complete.

Event Description

Clinician contacted dexcom technical support on (b)(6) 2015 to report a hardware failure that occurred on (b)(6) 2015.The patient did not report any injury or medical intervention.

Manufacturer Narrative

(b)(4).The complaint device was returned for evaluation.The device was visually inspected and "call tech support" error was observed on the screen.The data log could not be retrieved and functional testing could not be performed because of the "call tech support" error.The customer complaint could not be confirmed because it could not be determined if any error occurred on the date of event.The root cause could not be determined.

• 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: 5072322
• MDR Text Key: 26060720
• Report Number: 3004753838-2015-71500
• 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: consumer
• Reporter Occupation: Other
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• 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: 5202646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2014
• 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