MAUDE Adverse Event Report: THERMOMETER, ELECTRONIC, CLINICAL

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

Patient Problem Fever (1858)

Event Date 01/01/2017

Event Type  malfunction  

Event Description

The reporter has had misreadings on several oral digital thermometers used over the past three years.She wants the fda to know that there's a defect to all digital oral thermometers used in homes and healthcare facilities.The reporter has researched claims from various mfr's for testing accuracy; none of their calms have been true.To get a correct reading the reporter states that she has to leave the thermometer in her mouth for 10-14 minutes.The reporter states that she was not feeling well and thought that she may have a fever, she checked her temperature and the digital thermometer gave a normal reading.After several months and attempts with different digital thermometers she unable to get her correct reading.It wasn't until the she pull out an old mercury thermometer that was she able get correct readings and confirmed that she has a fever.Reporter states that her husband too was unable to get his flu vaccine because of inaccurate reading at a healthcare facility due to the use of an digital thermometer.

• Brand Name: THERMOMETER, ELECTRONIC, CLINICAL
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• MDR Report Key: 12908766
• MDR Text Key: 281840160
• Report Number: MW5105694
• Device Sequence Number: 4
• 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: 11/30/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White