BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KETOSENS BLOOD BETA-KETONE MONITORING SYSTEM

    MDR report key: 13354745 · Received January 26, 2022

    Report

    Report Number
    3005621222-2021-00012
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Date of Event
    December 28, 2021
    Report Date
    January 25, 2022
    Manufacturer
    I-SENS, INC.
    Product Code
    JIN
    PMA / PMN Number
    K170463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT METER WAS IMMEDIATELY DISCARDED BY THE CUSTOMER WHEN A PROBLEM OCCURRED, MAKING IT IMPOSSIBLE TO RETURN, AND THE SN COULD NOT BE VERIFIED. THEREFORE, I-SENS TRIED TO DETERMINE THE CAUSE OF EXCESSIVE HEAT IN THE METER BATTERY COMPARTMENT THROUGH HISTORY OF OCCURRENCE OF SIMILAR PROBLEMS, PRODUCT CHARACTERISTICS, AND REPRODUCIBILITY TEST. FIRST, WE CHECKED THE HISTORY OF SIMILAR PROBLEMS REPORTED WITH ALL THE METERS MANUFACTURED BY I-SENS IN THE LAST 5 YEARS, BUT NONE WERE FOUND. SECOND, AS A RESULT OF CHECKING THE POWER CONSUMPTION OF THE METER, IT IS VERY SMALL, WITH A MAXIMUM OF 0.03W, AND IT WAS CONFIRMED THAT THE POSSIBILITY OF GENERATING HEAT ENOUGH TO SMELL OF BURNING PLASTIC IS EXTREMELY LOW. FINALLY, THE KETOSENS METER OWNED BY I-SENS WAS TESTED UNDER THE ASSUMPTION THAT IT COULD GENERATE HEAT AS MUCH AS POSSIBLE. THIS MODEL WAS SHIPPED WITHOUT A BATTERY INSERTED, AND THE USER CONFIRMED THAT THE PROBLEM OCCURRED TWO WEEKS AFTER PURCHASE, SO WE TESTED THE SHORT-CIRCUIT CONDITION BY INSERTING ONE OF THE TWO BATTERIES REVERSELY AND LEAVING IT FOR TWO WEEKS. AS A RESULT, THE FINAL METER TEMPERATURE WAS 25.2 DEGREES AND NO OVERHEATING WAS CONFIRMED.

    Description of Event or Problem · 0

    A FEW DAYS BEFORE THE INITIAL CONTACT DATE (B)(6) 2021 THE USER WAS USING KETOSENS BT, THE METER BECAME EXCESSIVELY HEATED AND A SCENT OF BURNT PLASTIC WAS APPARENT. THE USER'S CHILD WAS IN THE SAME ROOM WHICH BOTH USER'S AND THE CHILD'S HEALTH AND SAFETY ISSUE WAS OBVIOUS. WHEN INQUIRED ABOUT RETURNING OF METER, DUE THE ABOVE REASON, THE METER WAS QUICKLY DISCARDED AND THAT NO ANALYSIS CAN BE COMMENCED TO THE PRODUCT OF THE INCIDENT. DUE TO THE PRODUCT BEING SOLD BY A THIRD PARTY SELLER, IT MAY BE DIFFICULT TO IDENTIFY PRODUCT INFORMATION OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831745 KETOSENS BLOOD BETA-KETONE MONITORING SYSTEM BLOOD BETA-KETONE MONITORING SYSTEM JIN I-SENS, INC. GM01GAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Female