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

Model Number MT22495-BLU

Device Problem Defective Alarm (1014)

Patient Problems Hypoglycemia (1912); Malaise (2359); Collapse (2416)

Event Date 09/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia.

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2017, the patient experienced no audio output on the receiver and an adverse event.Date of issue is an approximation.The patient stated they went to the bathroom and felt ill.They checked the receiver to see that they were experiencing low glucose levels and collapsed soon after.The patient indicated that the receiver alarm did not sound.The patient crawled to the phone and called for a nurse, who called 911.When the emergency medical technicians (emt) arrived, they checked the patient¿s blood glucose (bg) level and administered the patient with a shot of glucagon.The patient could not remember what the bg meter was reading at the time.The patient was transported and admitted to the hospital and was released on (b)(6) 2017.At the time of contact, the patient was feeling better.No additional patient or event information is available.No data was provided for evaluation.The complaint confirmation was unable to be determined.The probable cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 7248514
• MDR Text Key: 99243290
• Report Number: 3004753838-2018-013683
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10386270000177
• UDI-Public: 10386270000177
• 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: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495-BLU
• Device Catalogue Number: STK-DR-BLU
• Device Lot Number: 5202030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2015
• 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 Outcome(s): Other
• Patient Age: 74 YR