MAUDE Adverse Event Report: SHENZHEN FINICARE CO., LTD. FOREHEAD THERMOMETER, BABY AND ADULTS THERMOMETER WITH FEVER ALARM, LCD DISPLAY; THERMOMETER, ELECTRONIC, CLINICAL

Model Number FC-IR202

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Fever (1858)

Event Date 09/03/2022

Event Type  Injury  

Event Description

I purchased an ncit thermometer from amazon.Com on (b)(6) 2021.I've had numerous occasions where i haven't felt well, but the thermometer read a consistent 98.2 - 98.6 degrees.Recently, my partner and i contracted covid and were gifted an in-ear thermometer.We compared the outcomes of the ncit devices and the in-ear thermometer and they were vastly different.The ncit indicated that my partner had a temperature of 98.2 degrees, while the in-ear thermometer registered 101.4.My reading on the ncit was 98.4 and my in-ear reading was 99.7.This item is currently #1 in thermometers on amazon with over 72,000 reviews: https://www.Amazon.Com/digital-infrared- baby-thermometer-forehead/dp/b0824xnjsw/ref=rvi_sccl_1/143-8516984-8067600 while the outcome of this reading was not life threatening for me or my partner, the same might not be true for a child who doesn't understand their illness.Additionally, many public spaces use these thermometers to screen people for entry.How many people are inadvertently spreading an illness because this device has provided them with a "green" - normal - diagnosis.I have serious concerns about the accuracy of this device and think it should be pulled from the market.Fda safety report id# (b)(4).

• Brand Name: FOREHEAD THERMOMETER, BABY AND ADULTS THERMOMETER WITH FEVER ALARM, LCD DISPLAY
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): SHENZHEN FINICARE CO., LTD.
• MDR Report Key: 15379848
• MDR Text Key: 299568116
• Report Number: MW5111902
• 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: 09/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FC-IR202
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White