MAUDE Adverse Event Report: FRIDABABY LLC FRIDA BABY QUICK READ RECTAL THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number	61-088
Medical Device Problem Codes	Calibration Problem (2890); Output Problem (3005)
Health Effect - Clinical Codes	Distress (2329); Alteration in Body Temperature (4568)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
I am writing to file a complaint against the frida company, specifically regarding the fridababy quick read digital rectal thermometer, which provided repeated incorrect temperature readings of almost 3 degrees below the correct temperature on my infant son and resulted in an extremely invasive and stressful emergency hospital stay.I purchased the thermometer in (b)(6) 2021, in anticipation of my son's arrival in (b)(6) 2021.On (b)(6) 2021, my (b)(6) old son was fussy and felt warm, so i decided to check his temperature.The temperature read 96.5 degrees.This was very concerning ¿ infant cpr dictates that a temperature below 97 degrees requires a trip to the hospital.Over the next three hours my husband, home night nurse and i checked his temperature hourly.When it did not get above 97 degrees, i called my pediatrician, who advised that if the next reading was below 96.5, we should go to the emergency room.The next time we checked, we got a reading of 96 degrees.We went immediately to the er at (b)(6).What ensued was a harrowing three-day ordeal.A temperature below 97 degrees requires that an infant be treated for hypothermia, which includes tests through a blood draw (requiring an iv, which is very challenging to do on an infant and required two different teams of nurses), a catheter, a covid-19 test, and a lumbar puncture to do a bacterial culture on cerebrospinal fluid.It also required the administration of iv antibiotics.This was all done to our (b)(6) old and caused him (and his parents) enormous distress.After 7 hours in the er we were admitted to the hospital and required to stay a minimum of 48 hours while they grew bacterial cultures on the csf, urine and blood, and monitored his vital signs.His vital signs were checked regularly, and at no point while at the hospital, using hospital equipment, did his temperature measure outside of the range of 97.9-99.5.On (b)(6) i went home to gather a change of clothing and breast pump, and when i returned to the hospital, brought the fridababy thermometer with me.The next time a nurse checked our son's temperature, the hospital thermometer read 99.4.The nurse then immediately checked with the fridababy thermometer and it read 96.5 degrees.This is a 2.9 degree difference.Subsequent checks confirmed that the fridababy thermometer was always lower than the hospital thermometer by multiple degrees.We brought my son in for emergency treatment based on the low readings on the fridababy thermometer.This caused incredible stress physically, emotionally, financially, and on our time.We risked exposing our son to other illnesses, including covid-19, at the hospital during a critically vulnerable time in the development of his newborn immune system.In the end, it was clear this was all done based on inaccurate readings on the fridababy thermometer.It should be noted that after we realized that the temperature issue with our frida thermometer, my sister then checked her fridababy thermometer against another in her house ((b)(6) thermoscan) and it was 1.7 degrees lower.I can provide many tests from the hospital that all show my son was healthy and fine.Fda safety report id# (b)(4).

• Brand Name: FRIDA BABY QUICK READ RECTAL THERMOMETER
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): FRIDABABY LLC
• MDR Report Key: 11812045
• Report Number: MW5101298
• Device Sequence Number: 4020103
• Product Code: FLL
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 05/08/2021

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
• Operator of Device: Other
• Device Model Number: 61-088
• Device Lot Number: 51002811207663
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 1 MO
• Patient Weight: 5