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

Model Number 9500-27

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 03/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.Diabetes mellitus is a known cause of hypoglycemia and seizures.

Event Description

Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, that the patient experienced an adverse event.Patient reported experiencing a hypoglycemic event while the continuous glucose monitor (cgm) was displaying "???".Patient's wife reported she woke up and noticed patient was convulsing.Patient's wife called paramedics.Prior to emergency medical services (ems) arriving, patient reported that he drank 12 ounces of soda.Paramedics arrived and took patient's finger stick (fs).The fs blood glucose (bg) value was 30 mg/dl, while the cgm displayed "???".Paramedics treated the patient with an unknown iv solution and instructed him to eat some protein.Paramedics stayed with patient approximately 1.5 hours.Patient was not transported to hospital.At the time of contact, patient is well.No additional event or patient information is available the complaint states the patient experienced an error reading symbol on and an adverse event.Data was returned and evaluated.The reported error reading symbol event was confirmed via data.A root cause could not be 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: 6476618
• MDR Text Key: 72250595
• Report Number: 3004753838-2017-26279
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5218534(17)170919
• 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: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/19/2017
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5218534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2016
• 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: 47 YR
• Patient Weight: 88