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

Model Number 9500-45

Device Problem Imprecision (1307)

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

Event Date 07/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and loss of consciousness.

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the patient experienced an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter and a hypoglycemic event.The sensor was inserted into the arm on (b)(6) 2018.The patient stated they saw high values on the cgm and injected insulin based on the cgm reading and went to bed.The patient stated they experienced a hypoglycemic event while they were asleep which resulted in not waking up in the morning and called for emergency services.The patient's husband gave the patient orange juice and when emergency services arrived, they treated the patient with a glucose infusion.At the time of contact, the patient was doing fine.No additional patient or event information is available.No product or data was provided for investigation.Confirmation of the complaint was undetermined.The probable cause could not be determined.The sensor was inserted into the arm.Labeling indicates: sensor placement and insertion is not approved for sites other than the belly (abdomen).It was reported that the patient was taking medication containing acetaminophen.Labeling indicates: make sure you have not taken any medications containing acetaminophen (such as tylenol).

• 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: 7824328
• MDR Text Key: 118479971
• Report Number: 3004753838-2018-96727
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/06/2019
• Device Model Number: 9500-45
• Device Catalogue Number: STS-GF-004
• Device Lot Number: 5234746
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2018
• 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: 38 YR