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

Model Number MT22495-PNK

Device Problem Defective Alarm (1014)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced an intermittent audio output on the receiver and a hypoglycemic event.The patient stated that she had a low event while driving with the receiver in her purse.The patient did not recall hearing the alert or having symptoms before passing out and waking up inside the ambulance with a blood glucose (bg) value of 24 mg/dl.The patient was advised that she had driven off the curb with no damage to anyone else and without physical injury to herself.The patient did not know who called the emergency medical technicians (emt's), but was not taken to the hospital and was released on site.The current condition of the patient is normal.No additional patient or event information is available.No product was provided for evaluation.The complaint confirmation of intermittent audio output could not be determined.A root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 7022683
• MDR Text Key: 91851042
• Report Number: 3004753838-2017-98420
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10386270000160
• UDI-Public: 10386270000160
• 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: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495-PNK
• Device Catalogue Number: STK-DR-PNK
• Device Lot Number: 5224400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2017
• 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): Other
• Patient Age: 75 YR