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

Catalog Number STS-GL-011

Device Problem Invalid Sensing (2293)

Patient Problem Seizures (2063)

Event Date 02/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.Product code pqf is not currently available in common device name.

Event Description

Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the patient experienced continuous glucose monitoring (cgm) inaccuracies and an adverse event.Sensor was inserted at the abdomen on (b)(6) 2017.Patient reported experiencing a seizure.Patient asserts that the seizure was due to the inaccuracies.Patient reported cgm blood glucose (bg) value was 381 mg/dl, while a bg meter value was 196 mg/dl.There was no report of medical intervention.At time of contact, patient is stable.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 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: 6381932
• MDR Text Key: 69178081
• Report Number: 3004753838-2017-15886
• 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: 02/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: STS-GL-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2017
• 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
• Treatment: AMLODIPINE BESYLATE; ATROVASTATIN; HYDROCHLOROTHIAZIDE; MYLANTA; SYNTHROID
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 91