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

Model Number MT22495

Device Problem Defective Alarm (1014)

Patient Problems Bruise/Contusion (1754); Hypoglycemia (1912)

Event Date 08/09/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on 08/17/2016 that the patient experienced intermittent audio output from the receiver and a low event on (b)(6) 2016.Patient reported that he had a low and didn't notice the alert from his continuous glucose monitor (cgm).The patient was involved in a minor car accident in which he drove off the road and went off a small hill and had to have the vehicle pulled out.The patient was transported to the hospital by an ambulance, was given liquid glucose and was admitted to the hospital for observation.Additionally, patient had a blood glucose level of 31mg/dl when checked by the ambulance.While in the hospital the patient was administered 40 grams of glucose tabs.Patient sustained a bruise on the elbow from the accident.At the time of contact, the patient was not having any lows and the bruise had healed.No additional event or patient information was provided.The complaint device was returned for investigation.The device was determined to be in good condition based on external visual inspection.Review of log data did not find any errors related to the customer complaint.Global receiver functional testing resulted in no failures related to the complaint.The reported fault could not be reproduced with the receiver.The event of intermittent audio output could not be confirmed.The 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 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: 5940082
• MDR Text Key: 54347774
• Report Number: 3004753838-2016-80308
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000156
• UDI-Public: (01)00386270000156(241)MT22495(10)5202043(17)NA
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/17/2016

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
• Device Catalogue Number: STK-DR-001
• Device Lot Number: 5202043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3004753838-02/29/16-001C
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 60 YR
• Patient Weight: 77