MAUDE Adverse Event Report: FITBIT FITBIT CHARGE 2 ANALYZER, BODY COMPOSITION

Device Problem Insufficient Information (3190)

Patient Problems Dizziness (2194); Test Result (2695)

Event Date 10/24/2017

Event Type  Injury  

Event Description

Received fitbit charge 2 device as a free gift from my employer to record my physical activity and began using it on (b)(6) 2017. After a week or so of use i started having dizzy spells. At one point while driving, i had to pull off the road at one point because i could no longer see the road. Coincidentally, i had my yearly physical on (b)(6) 2017. Blood tests revealed hypothyroidism: tsh
=
9. 96, free t4
=
0. 8, and t4 total
=
4. 7. I had a problem with my thyroid in the past, however, i've been off medication for over 2 years. I stopped using the device (b)(6) 2017.

• Brand Name: FITBIT CHARGE 2
• Type of Device: ANALYZER, BODY COMPOSITION
• Manufacturer (Section D): FITBIT
• MDR Report Key: 7159835
• MDR Text Key: 96335546
• Report Number: MW5074387
• Device Sequence Number: 1
• Product Code: MNW
• 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
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 01/02/2018 Patient Sequence Number: 1