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

Model Number MT22495-BLU

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

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

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Patient's mother contacted dexcom on (b)(6) 2016 to report that the receiver displayed a firmware error on (b)(6) 2016.The patient's mother did not report injury or medical intervention.No additional patient or event information is available.It was reported that a pediatric patient was using a receiver approved only for adults.It should be noted that the dexcom g4 platinum continuous glucose monitoring system states: the dexcom g4 system is not approved for use in children or adolescents, pregnant women or persons on dialysis.

Manufacturer Narrative

(b)(4).

Event Description

The complaint device was returned for evaluation.The device was visually inspected and no defect was found.The receiver log was reviewed and did not find any errors related to the customer complaint.The reported event of a firmware error was not confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE 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: 5429194
• MDR Text Key: 38290047
• Report Number: 3004753838-2016-31640
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000170
• UDI-Public: (01)00386270000170(241)MT22495-BLU(10)5205016(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: 01/14/2016

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: MT22495-BLU
• Device Catalogue Number: STK-DR-BLU
• Device Lot Number: 5205016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• 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: 5 YR