BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KETONE

    MDR report key: 11718609 · Received April 23, 2021

    Report

    Report Number
    1000113657-2021-00277
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 28, 2021
    Report Date
    April 23, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    JIN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). KETONE TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE: MANUFACTURER CONTACTED CUSTOMER BY E-MAIL AND FOLLOW-UP CALL TO ENSURE THE INITIAL CONCERN IS RESOLVED. UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT BY E-MAIL FOR ERRATIC RESULTS WHEN USING THE KETONE TEST STRIPS. CUSTOMER REPORTED SHE HAD OBTAINED TWO DIFFERENT RESULTS TESTING USING THE SAME URINE STREAM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617490 KETONE NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) JIN TRIVIDIA HEALTH INC STRIP, KETONE 50CT

    Patients

    Seq Age Sex Outcome Treatment
    1