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

Model Number MT20649-1

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2018

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 no audio output.No additional event or patient information is available.No product or data were provided for evaluation.The reported no audio output could not be determined.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The product was evaluated.An external visual inspection was performed and passed.The receiver was charged and rebooted.Receiver download was retrieved and attached.The log was downloaded and reviewed finding no errors related to the complaint.A functional test was performed and it failed audio.The receiver case was opened for an internal visual inspection and it passed.Receiver speaker resistance was measured and failed.The allegation was confirmed.The probable cause was defective speaker.No injury or medical intervention was reported.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• 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: ashley spoto ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 8112046
• MDR Text Key: 128934033
• Report Number: 3004753838-2018-148351
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-1
• Device Catalogue Number: STR-GL-004
• Device Lot Number: 5220392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• 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: 12 YR
• Patient Weight: 47