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

Model Number MT20649-BLU

Device Problem Defective Alarm (1014)

Patient Problems Stroke/CVA (1770); Hypoglycemia (1912)

Event Date 03/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2016 to report an adverse event and intermittent audi ouput that occurred on (b)(6) 2016.The patient experienced a hypoglycemic event and had a diabetic stroke.Patient gave himself a glucagon shot.Patient did not receive medical attention.No additional event or patient information was reported.

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2016 to report an adverse event and intermittent audio output that occurred on (b)(6) 2016.Subsequent to the initial mdr, additional information was received from the patient regarding their diabetic stroke.The patient stated they had a low and that they only intermittently hear the alarm go off.Patient stated that they have had so many lows that they frequently go into diabetic comas.The patient has a bad pancreas and has too much scarring.No other patient or event information is available.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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: 5566489
• MDR Text Key: 42260010
• Report Number: 3004753838-2016-37116
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000095
• UDI-Public: (01)00386270000095(241)MT20649-BLU(10)5166425(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: Notification
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-BLU
• Device Catalogue Number: STK-GL-BLU
• Device Lot Number: 5166425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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: 63 YR
• Patient Weight: 79