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

Model Number 9500-27

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hypoglycemia (1912); Vomiting (2144)

Event Date 04/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and its associated effects.

Event Description

Dexcom was made aware on (b)(6) 2016 of an adverse event the patient experienced on (b)(6) 2016.Patient's wife was on the phone with technical support (ts) regarding calibration, as her husband was unable to give directions.During the call, the ts representative could hear the patient vomiting and gasping for air.Patient was also heard mumbling and was unable to talk.Patient's wife was advised to call 911 because the patient sounded like he was having an emergency.Patient later gave an update regarding the event, stating that he had dropped very low, quickly and before he could respond was incoherent.Patient's wife called an ambulance and when the paramedics came he was stable due to the juice he had.Patient did not require any medical attention from the paramedics.There was no alleged device malfunction.No additional event or patient information was provided.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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: 5684159
• MDR Text Key: 46061434
• Report Number: 3004753838-2016-03235
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)NI(17)NI
• 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: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 59 YR