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

Model Number 9500-27

Device Problems Use of Device Problem (1670); Invalid Sensing (2293)

Patient Problems Fainting (1847); Hypoglycemia (1912)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(4)2017, that on (b)(6)2017, the patient experienced continuous glucose monitoring (cgm) inaccuracies and an adverse event.The date of issue is an approximation.The sensor was inserted into the arm on (b)(6)2017.The patient stated that due to the inaccurate cgm values, they had a hypoglycemic event, fainted and went to the emergency room (er).At the time of contact, the patient was in stable condition and was following up with their primary care physician.No further event details were provided.No additional patient or event information is available.No product or data were provided for evaluation.The reported event could not be confirmed.A root 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).The patient is a pregnant user.Labeling indicates: the dexcom system is not approved for use in children or adolescents, pregnant women or persons on dialysis.

• 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: 6712976
• MDR Text Key: 80008640
• Report Number: 3004753838-2017-57812
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5222691(17)180118
• 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: 06/15/2017

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 Expiration Date: 01/18/2018
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5222691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2017
• 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: 24 YR
• Patient Weight: 82