BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINSA QUICK CARE THERMOMETER

    MDR report key: 11574314 · Received March 25, 2021

    Report

    Report Number
    MW5100276
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    February 26, 2021
    Report Date
    March 23, 2021
    Manufacturer
    KINSA INC.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    USED KINSA RECTAL THERMOMETER ON MY (B)(6) SON AND IT PROVIDED A READING OF 100.6, NECESSITATING A TRIP TO THE ER. MY SON WAS ADMITTED FOR 36 HOURS AND SUBJECTED TO A BATTERY OF TESTS BASED ON THE KINSA READING, DESPITE HIM NEVER HAVING A FEVER OR A HIGH TEMPERATURE WHILE IN THE HOSPITAL. A FEW WEEKS LATER HE DEVELOPED A MILD COLD AND THE KINSA THERMOMETER AGAIN GAVE MULTIPLE READINGS OF OVER 100 DEGREES. BASED ON THESE READINGS, I TOOK MY SON TO URGENT CARE, WHERE HIS TEMPERATURE WAS 98.6. I FINALLY WENT OUT AND PURCHASED ANOTHER THERMOMETER TO COMPARE TO THE KINSA, AND DETERMINED THAT THE KINSA IS OFF BY AT LEAST 1 DEGREE, CAUSING HIGHER THAN ACTUAL TEMPERATURES. IN THE CASE OF NEWBORN BABIES THIS IS ABSOLUTELY UNACCEPTABLE. FDA SAFETY REPORT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469726 KINSA QUICK CARE THERMOMETER THERMOMETER, ELECTRONIC, CLINICAL FLL KINSA INC. KSA-110

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Hospitalization