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

Model Number MT22495

Device Problem Defective Alarm (1014)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced no alerts on the receiver and an adverse event.On (b)(6) 2017, the patient was at work and stated that the alarm did not sound on the receiver.It was indicated that at 9:00am, the data on the receiver was showing that they were below 80 mg/dl and then below 50 mg/dl at 9:30am.The patient walked to a meeting at 10:00am and did not remember anything after that.The patient's coworkers at the meeting noticed that the patient was not responding to conversation but did not hear any alerts and presumed that the patient was having a low event.It was indicated that 10 minutes later, the patient went into seizures and a coworker called 911.When the paramedics arrived, they checked the patient's glucose reading and it was reading 19 mg/dl.The paramedics treated the patient with glucodon and glucose gel and the patient came to.At the time of contact, the patient was doing good.No additional patient or event information is available.The device has been received for evaluation.  a follow-up report will be submitted once the evaluation is complete. .

Manufacturer Narrative

(b)(4).

Event Description

The complaint device was returned for evaluation.The device was visually inspected and no defects were found.The receiver will boot and charge.The receiver download did not show any errors.A "try it" manual test try it was performed and pass.The receiver functional test was performed and pass.Open receiver case for internal visual inspection, pass.Perform speaker audio intermittent tests, pass measure the speaker resistance.Speaker resistance within specification.The reported event of an intermittent audio output was not confirmed.A 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: 6993968
• MDR Text Key: 90791901
• Report Number: 3004753838-2017-97557
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10386270000153
• UDI-Public: 10386270000153
• 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,Followup
• Report Date: 10/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495
• Device Catalogue Number: STK-DR-001
• Device Lot Number: 5224650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2016
• 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: 33 YR
• Patient Weight: 110