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

Model Number MT22430-BLU

Device Problem Defective Alarm (1014)

Patient Problems Virus (2136); Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 03/18/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient's mother contacted dexcom on (b)(6) 2016 to report that the patient experienced intermittent audio output and an adverse event on (b)(6) 2016.Patient's mother stated that the patient started vomiting at 5:23 in the morning.At the time of the event, the patient's continuous glucose monitor (cgm) was reading 363mg/dl.Patient's mother stated that the receiver did not alarm.The patient's mother drove the patient to convenient care and from there, an ambulance was called and they were taken to the hospital.Patient was given an iv of fluids, anti-vomiting medication and insulin via the vein.Patient was put on a heart monitor and it was reported that their co2 was low.Patient was diagnosed with diabetic ketoacidosis and also had a virus.Patient was at the hospital until (b)(6) 2016.At the time of contact, patient was in good condition.Additionally, patient's mother tested the receiver's high alert and it did work.No additional event or patient information was provided.

• Brand Name: DEXCOM G4 PLATINUM PEDIATRIC 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: 5615224
• MDR Text Key: 43893194
• Report Number: 3004753838-2016-02619
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000118
• UDI-Public: (01)00386270000118(241)MT22430-BLU(10)5195747(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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22430-BLU
• Device Catalogue Number: STK-KD-BLU
• Device Lot Number: 5195747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2014
• 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: 10 YR
• Patient Weight: 28