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

Model Number MT20649-2

Device Problem Failure to Charge (1085)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, the patient experienced receiver does not hold charge.No additional patient or event information is available.The complaint receiver device was returned for evaluation.The device was visually inspected and no defect was found.The receiver failed to charge and reboot.The receiver was opened for an internal visual inspection, we observed damaged solder pins on the battery controller chip which prevented the receiver's battery from holding the charge.A known good battery was installed and a download performed.Upon review we found rtt loss followed by set time screen within the investigation window.While in the sensor session, unit shut down unexpectedly and did not recover interrupting the sensor session.Test on receiver functional test station with a good know battery passed.The reported event receiver does not hold charge was confirmed and an unexpected receiver shutdown was observed.The root cause of receiver's battery not able to hold charge is a damaged battery.

• Brand Name: DEXCOM G4 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: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 7688149
• MDR Text Key: 114303701
• Report Number: 3004753838-2018-77137
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MT20649-2
• Device Catalogue Number: STK-GL-117
• Device Lot Number: 5223577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2018
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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