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

Model Number MT22495-PNK

Device Problems Device Displays Incorrect Message (2591); Moisture or Humidity Problem (2986)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device was not returned for evaluation and data was not provided; therefore, the reported complaint of hardware error cannot be confirmed.It was reported that patient's receiver was exposed to water.It should be noted that the dexcom g4® platinum continuous glucose monitoring system states: keep the receiver dry.Do not spill fluids on it or drop it into fluids.However, a root cause for the reported hardware error cannot be determined.

Event Description

Patient contacted dexcom technical support on (b)(6) 2015 to report that the receiver displayed a hardware error on (b)(6) 2015.Patient's receiver was exposed to water.At the time of contact, no injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

Event Description

The returned complaint device was visually inspected and no defects were found.A hardware error code was observed during a review of the downloaded data log.The reported event of a hardware failure was confirmed.The root cause was determined to be a hardware component failure.The dexcom g4 platinum continuous glucose monitoring system rev.11, under section 13.8.2 receiver error code notes the following: this screen shows an error code that means the receiver may not be working properly.Write down the error code and contact dexcom technical support.Continue to check your blood glucose value using your blood glucose meter.No alert sound or vibration will warn you that you are no longer getting sensor glucose readings.

• 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: 5129756
• MDR Text Key: 27928120
• Report Number: 3004753838-2015-72046
• 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
• Type of Report: Followup
• Report Date: 09/08/2015

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-PNK
• Device Catalogue Number: STK-DR-PNK
• Device Lot Number: 5200553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2015
• 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: 56 YR