MAUDE Adverse Event Report: KINSA INC. KINSA SMART STICK THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Device Problem High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2022

Event Type  malfunction  

Event Description

I have a kinsa smart stick thermometer and the temperature that it reports is always higher than the temperature i get from a traditional mercury thermometer or a digital thermometer.The temperature is randomly high so you can take two readings and the readings will be different even within the same minute.Fda safety report id# (b)(4).

• Brand Name: KINSA SMART STICK THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): KINSA INC.
• MDR Report Key: 15066958
• MDR Text Key: 296307926
• Report Number: MW5110970
• Device Sequence Number: 1
• Product Code: FLL
• 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: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2022
• Patient Sequence Number: 1
• Patient Sex: Male