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

Model Number MT22719-BLU

Device Problems No Audible Alarm (1019); Use of Device Problem (1670)

Patient Problem Seizures (2063)

Event Date 09/18/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(6) 2016 that on (b)(6) 2016, the patient experienced no audio alert from the receiver and an adverse event.Patient's mother reported that patient experienced a seizure in her kitchen due to the audio alert not sounding.The patient's mother called 911.Patient was taken to the emergency room (er).Patient's mother reported patient having blood work and a computerized tomography (ct) scan, but no treatment was given.No additional event or patient information is available.No product was provided for evaluation.Data was received for evaluation.However, an evaluation cannot be performed to confirm the reported issue.A root cause could not be determined.The sensor was inserted into the arm.The dexcom g5 mobile continuous glucose monitoring system states: do not insert the sensor component of the dexcom g5 mobile system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years).The placement and insertion of the sensor component of the dexcom g5 mobile system is not approved for other sites.If placed in other areas, the dexcom g5 mobile system may not function properly.

• 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: 6018696
• MDR Text Key: 57045595
• Report Number: 3004753838-2016-84236
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000279
• UDI-Public: (01)00386270000279(241)MT22719-BLU(10)5213127(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: Recall
• Type of Report: Initial
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22719-BLU
• Device Catalogue Number: STR-GF-BLU
• Device Lot Number: 5213127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3004753838-02/29/16-001C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR
• Patient Weight: 57