MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 05/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a possible contributor for stroke.

Event Description

Dexcom was made aware on (b)(6) 2016 that on (b)(6) 2016, that the patient experienced an adverse event.Patient reported that she was with several friends when she experienced a stroke.One of the friends was a nurse, who recognized the stroke symptoms and took the patient to the emergency room (er).Patient reported that she was treated with a "clot busting drug." patient was hospitalized and discharged on (b)(6) 2016.It is not known if patient was wearing the continuous glucose monitor (cgm) at the time of event.There was no alleged device malfunction.At the time of contact, patient is okay.No additional event or patient 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.

• Brand Name: DEXCOM G5 MOBILE 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: 6247135
• MDR Text Key: 64661845
• Report Number: 3004753838-2017-01146
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Public: (01)NI(241)NA(10)NI(17)NI
• 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: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 66 YR
• Patient Weight: 66