MAUDE Adverse Event Report: DIGITAL NON CONTACT INFRARED THERMOMETER CICADA; THERMOMETER, ELECTRONIC, CLINICAL

Model Number UX-A-01

Device Problem Low Readings (2460)

Patient Problem Fever (1858)

Event Date 08/27/2020

Event Type  malfunction  

Event Description

Due to covid-19, i ordered an infrared thermometer to check the temperatures of family/friends to screen them when they enter our home.I thought it was working because it gave a temperature reading and showed no errors or any other indication that the device was not working properly.However, when my husband became sick on (b)(6) 2020 with an obvious fever and i checked his temperature, the device showed it to be normal - even on the low side - between 96.9 and 97.8 degrees fahrenheit.Because it was obvious that my husband was running a fever, i used an oral thermometer to verify and found that his temperature was over 100.We did further testing over the next few days comparing the infrared device to the oral thermometer and found that the infrared device was consistently inaccurate.The higher the patient's temperature, the more inaccurate the reading.I contacted (b)(6), the seller (via (b)(6)), to notify them and request a refund; however, they have not cooperated.My concern is that others may be using this device to screen for covid-19 and putting themselves and others at risk due to the defective device.Fda safety report id# (b)(4).

• Brand Name: DIGITAL NON CONTACT INFRARED THERMOMETER CICADA
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• MDR Report Key: 10605637
• MDR Text Key: 209369034
• Report Number: MW5096935
• Device Sequence Number: 1
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/25/2020

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: Other
• Device Model Number: UX-A-01
• Device Catalogue Number: NOT FOUND
• Device Lot Number: 20200503
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 109