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

Model Number 9500-27

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Shock (2072)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced pain due to a shock from the sensor.The sensor was inserted into the abdomen on (b)(6) 2016.The patient reported that the shocking sensation occurred every 10-15 minutes and was similar to static shock.On (b)(6) 2016, the patient contacted her endocrinologist's office and spoke with a nurse about the shock.Patient was advised to contact dexcom.On (b)(6) 2016, the patient reported additional information.Patient stated that she has experienced shocks similar to a carpal tunnel test or touching a piece of metal in the winter, for approximately one month.The patient experienced this issue approximately one month after starting a new transmitter and it has occurred with several sensors.The patient saw her endocrinologist regarding the issue and the endocrinologist used a paperclip to test the current of the transmitter.No significant findings were discovered.The patient stated that the endocrinologist felt that the issue did not warrant any further medical investigation.At the time of contact, the patient was healthy.Additional event or patient information is not available.The sensor was returned for investigation.The sensor was visually inspected, however, further testing was unable to be performed.The returned product was not investigated as analysis would not be able to confirm the complaint or determine the potential root cause.The customer complaint was not confirmed.A root cause was not determined.

• Brand Name: DEXCOM G5 MOBILE 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: 6084536
• MDR Text Key: 59330025
• Report Number: 3004753838-2016-80789
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5215260(17)170726
• 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: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/26/2017
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-041
• Device Lot Number: 5215260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 70