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

Model Number MT22719-BLU

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

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 05/11/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient's wife contacted dexcom on (b)(6) 2016 to report that the patient experienced a hypoglycemic event on (b)(6) 2016.Patient had seizure at about 3:30-3:40 central time.The patient's wife took the receiver out of the patient's pocket and saw that the continuous glucose monitor (cgm) displayed a value of 50mg/dl.Patient's wife reported a fingerstick value of between 50-60mg/dl.The patient had apple juice and then the ambulance came and gave him something.Patient's wife did not know what the emt's gave the patient.Fingerstick value was then 250mg/dl.The patient was taken to the hospital via ambulance.The patient was given an iv and had an electrocardiogram (ekg) performed.Additionally, patient's wife stated that during the seizure the patient bit his tongue.At the time of contact, the patient could not talk and had a sore throat.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: 5710361
• MDR Text Key: 47084191
• Report Number: 3004753838-2016-03416
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000279
• UDI-Public: (01)00386270000279(241)MT22719-BLU(10)5206576(17)NA
• 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: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MT22719-BLU
• Device Catalogue Number: STK-GF-BLU
• Device Lot Number: 5206576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2015
• 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): Hospitalization; Other
• Patient Age: 62 YR
• Patient Weight: 101