MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5; SENSOR, GLUCOSE, INVASIVE

Model Number G5

Device Problem Material Integrity Problem (2978)

Patient Problems Hypoglycemia (1912); Myocardial Infarction (1969)

Event Type  No Answer Provided  

Event Description

Made the mistake of trusting the dexcom g5 glucose monitor.It loses contact with the monitor constantly.One night my blood glucose went way low and it did not alert me.I woke up having a heart attack.

• Brand Name: DEXCOM G5
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 7789181
• MDR Text Key: 117567894
• Report Number: MW5079187
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Model Number: G5
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR