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 Problems Myocardial Infarction (1969); Pneumonia (2011)

Event Date 07/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is known contributor to the increased risk for developing cardiovascular disease.

Event Description

Dexcom was made aware on 08/24/2016, that on (b)(6) 2016, the patient experienced a mild heart attack at approximately 9:30 a.M.Patient's husband thought she was experiencing a low but after giving her juice, decided something else was going on.The patient's husband drove her to the hospital and the issues discovered were heart attack and pneumonia.The patient was administered an i.V.And lasix to drain excess fluid, as well as antibiotics for the pneumonia.Patient reported that at the time of the event, the dexcom continuous glucose monitor (cgm) was working fine.There was no alleged device malfunction.No additional event or patient information was provided.No product or data was returned for investigation.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: 5959137
• MDR Text Key: 54990572
• Report Number: 3004753838-2016-80313
• Device Sequence Number: 1
• Product Code: MDS
• 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: 08/24/2016

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 65 YR