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

Model Number 9500-27

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Blurred Vision (2137); Dizziness (2194); Cognitive Changes (2551)

Event Date 06/02/2016

Event Type  Injury  

Manufacturer Narrative

Diabetes mellitus is a known cause of hypoglycemia.

Event Description

Patient contacted dexcom on (b)(6) 2016 to report a sensor failure prior to double blood drop and an adverse event that occurred on (b)(6) 2016.The sensor was inserted in the abdomen on (b)(6) 2016.The patient stated that his sensor failed which caused him to have a diabetic low.Patient was at the doctor's office when sensor failed and minutes later he told the doctor he was feeling dizzy and everything was very blurry.Patient 'zombied' out at a blood glucose value of 38mg/dl.Patient's doctor called a 'code blue'.Patient's doctor gave the patient orange juice with three packets of sugar.The emergency room team put an intravenous sugar solution in the patient and brought him to the emergency room at 1:20pm and then was discharged to go home at 7:30pm on (b)(6) 2016.At time of contact current condition of the patient was fine.No additional event or patient information was provided.

Manufacturer Narrative

(b)(4) correction to remove- 'product problem', correction to remove- "the patient stated that his sensor failed which caused him to have a diabetic low.", if follow-up, what type?: correction, device code- correction.

• Brand Name: DEXCOM G4 PLATINUM 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: 5764103
• MDR Text Key: 48613384
• Report Number: 3004753838-2016-03623
• 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,Followup
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2016
• 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: 56 YR
• Patient Weight: 89