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

Model Number MT20649-2

Device Problem Low Audible Alarm (1016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, the receiver had low audio output.No additional event or patient information is available.No product was provided for evaluation.The complaint confirmation of the receiver having low audio output could not be determined.A probable cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The receiver was returned for evaluation.An exterior visual inspection was performed and passed.The receiver was charged and will boot.The receiver log was downloaded and reviewed, finding no errors related to the complaint.A global receiver functional test was performed and passed.Manual "try it" testing and was performed and passed.A manufacturing mode/sound test was performed and passed.The receiver case was opened for an interior inspection and passed.Speaker resistance was measured and passed.The reported event of a low audio output was not confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 8203650
• MDR Text Key: 131725283
• Report Number: 3004753838-2018-162567
• 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,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-2
• Device Catalogue Number: STK-GL-113
• Device Lot Number: 5232676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2017
• 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: 7 YR
• Patient Weight: 29