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 Myocardial Infarction (1969)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.Diabetes mellitus can potentially to lead to cardiovascular complications.

Event Description

Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, patient suffered a heart attack.Patient reported experiencing chest pains but was not aware she was having a heart attack.On (b)(6) 2017, the patient's husband took patient to her primary care physician.A blood test was positive for enzymes that confirmed the heart attack.Patient was admitted to hospital on (b)(6) 2016.Patient was treated with two (2) stints installed and was discharged on (b)(6) 2016 patient was wearing the dexcom system at the time of the event.There was no alleged device malfunction.No additional event or patient information is available.No product or data was provided for evaluation.The customer complaint 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: 6559101
• MDR Text Key: 74887859
• Report Number: 3004753838-2017-26417
• 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: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• 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: 04/11/2017
• 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
• Treatment: BABY ASPIRIN; BRILLINTA; IBUPROPHEN; TENORMIN
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 59 YR
• Patient Weight: 122