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

Model Number 9500-27

Device Problem Invalid Sensing (2293)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on 03/24/2017 that on (b)(6) 2017, the patient experienced continuous glucose monitoring (cgm) inaccuracies and a hypoglycemic event.Patient's mother reported that the continuous glucose monitor (cgm) did not alert.Patient had a seizure, hit his face on a coffee table, and received facial bruising.Patient's blood glucose (bg) was 45 mg/dl at the time of event.No separate glucose values were provided for comparison of cgm and finger stick bg.Patient was treated with a glucagon shot.Patient's mother call 911.Emergency medical technicians (emts) took patient to emergency room (er).Patient's bg was over 100 mg/dl at time of release from er.At time of contact, patient is fine.No additional event or patient information is available.No product or data was provided for investigation.The reported issue could not be confirmed.The root 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 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: 6507906
• MDR Text Key: 73326471
• Report Number: 3004753838-2017-26310
• 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
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2017
• 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: 12 YR
• Patient Weight: 35