MAUDE Adverse Event Report: FRIDABABY LLC. FRIDABABY 3-IN-1TRUE TEMPERATURE DIGITAL THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 61-067

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

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

Event Date 10/12/2022

Event Type  Injury  

Event Description

We checked our newborns temperature using the fridababy 3 in 1 thermometer receiving a reading of 100.5f on a rectal temperature.We were advised to go the emergency department and our newborn was hospitalized and underwent invasive procedures (lumbar puncture) based on this temperature reading.She never registered a fever in the hospital.I went home and retrieved the fridababy thermometer and took several rectal temperatures in order to correlate the thermometer with hospital thermometer readings.The fridababy thermometer continued to result a rectal temperature of 100.5 f throughout the admission despite our newborn never registering a temperature on any other thermometer used throughout the hospitalization.All of her cultures and lab work were completely normal.It appears the fridababy thermometer is giving an inaccurate and falsely high reading which lead to an unnecessary hospitalization in our case.Fda safety report id# (b)(4).

• Brand Name: FRIDABABY 3-IN-1TRUE TEMPERATURE DIGITAL THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): FRIDABABY LLC.
• MDR Report Key: 15632291
• MDR Text Key: 302064480
• Report Number: MW5112710
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 61-067
• Device Lot Number: 51002804216292
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 17 DA
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White