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

Model Number 9500-44

Device Problems Imprecision (1307); Use of Device Problem (1670)

Patient Problem Loss of consciousness (2418)

Event Date 09/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced an inaccuracy between the continuous glucose monitor (cgm) and an adverse event.The sensor was inserted into the abdomen on (b)(6) 2017.On the morning of (b)(6) 2017 at approximately 12:15 am, the patient's mother checked on the patient and was unable to wake them up because they were unconscious.The patient's mother and father proceeded to administer the patient with 2 glucagon shots and after 20 minutes, the patient was alert and awake.At 12:45 am, the patient was given fruit to eat.At the time of contact, the patient was doing good.No additional patient or event information is available.No data was provided for evaluation.The reported event of inaccuracies was unable to be determined.A root cause could not be determined.It was reported that the patient used multiple bg meters throughout the same sensor session.Dexcom labeling indicates: use the same meter you routinely use to measure your blood glucose to calibrate.Do not switch your meter in the middle of a sensor session.Blood glucose meter and strip accuracy vary between blood glucose meter brands.

• 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: 6983608
• MDR Text Key: 90431935
• Report Number: 3004753838-2017-91793
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2017

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: 9500-44
• Device Catalogue Number: STS-GF-007
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/27/2017
• 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: 17 YR
• Patient Weight: 40