MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS MONITORING SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number MT22719

Device Problem Failure to Charge (1085)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016 the receiver would not hold a charge.No additional event or patient information is available.Complaint device was returned for evaluation.A visual exterior inspection was performed on the receiver and it passed.Receiver data logs were downloaded and reviewed, finding a screen error alarm , in addition to a hardware error and a "ntcfault".Based on the finding of a screen error alarm this is being reported.The complaint was confirmed.The root cause was determined to be a bad receiver battery, post investigation.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS 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: 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 6183635
• MDR Text Key: 62707300
• Report Number: 3004753838-2016-81045
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000231
• UDI-Public: (01)00386270000231(241)MT22719(10)5219484(17)NA
• 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
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22719
• Device Catalogue Number: STR-GF-001
• Device Lot Number: 5219484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2016
• 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: 36 YR
• Patient Weight: 82