BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOOKO MOBILE INSULIN DOSING SYSTEM

    MDR report key: 22161438 · Received June 6, 2025

    Report

    Report Number
    MW5171159
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Report Date
    May 30, 2025
    Manufacturer
    GLOOKO, INC.
    Product Code
    NDC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR MW5171159 ON JULY 2, 2025, TO UPDATE PROCODE. PROCODE: NDC.

    Description of Event or Problem · 0

    DURING IN-PERSON ENCOUNTER YESTERDAY WITH A PATIENT WITH TYPE 1 DIABETES MELLITUS ON THE OMNIPOD 5 INSULIN PUMP, HER PUMP SETTINGS ON HER PDM/PUMP CONTROLLER WERE VERY DIFFERENT FROM WHAT WAS REPORTED ON THE GLOOKO PUMP REPORT. AFTER DISCOVERING THIS DISCREPANCY WHILE MAKING PUMP SETTINGS ADJUSTMENTS, WE CALLED OUR LOCAL OMNIPOD REPRESENTATIVE WHO INFORMED THAT THERE HAVE BEEN ISSUES WITH THE GLOOKO REPOST NATIONWIDE, FOR AN UNKNOWN DURATION AND WITH AN UNKNOWN RESOLUTION TIME. THERE WAS NO EMAIL OR NOTIFICATION SENT TO PRESCRIBERS NOR PATIENT'S REGARDING INCORRECT GLOOKO REPORTS. ANOTHER OMNIPOD 5 PATIENT PRESENTED YESTERDAY VIRTUALLY FOR FOLLOW-UP, AND ALL OF THE PUMP SETTINGS SHE WAS READING OFF OF HER CONTROLLER OVER THE VIDEO CALL WERE VASTLY DIFFERENT FROM WHAT THE SETTINGS WERE ON HER GLOOKO REPORT. THE PURPOSE OF HER VISIT WAS TO HELP CONTROL HER BLOOD SUGARS BETTER HOWEVER I WAS UNABLE TO ADJUST HER SETTINGS GIVEN HER REPORTED SETTINGS WERE COMPLETELY INACCURATE FOR WHAT HER ACTUAL PDM CONTROLLER SETTINGS WERE. OMNIPOD HAS A RESPONSIBILITY FOR ENSURING THAT THEIR TECHNOLOGY HAS ACCURATE AND RELIABLE REPORTING ACCESSIBLE TO PRESCRIBERS AND PATIENTS. UNFORTUNATELY, THEY HAVE CHOSEN NOT TO NOTIFY USERS AROUND THE COUNTRY, WHICH CAN RESULT IN SERIOUS PATIENT'S SAFETY RISKS WITH THEIR INCORRECT SETTINGS BEING ADJUSTED TO CONTROL FURTHER BLOOD SUGARS. THIS COULD RESULT IN SERIOUS SAFETY ISSUES FROM SEVERE HYPERGLYCEMIA OR HYPOGLYCEMIA. PRESCRIBER SHOULD HAVE BEEN NOTIFIED AND SHOULD BE UPDATED WITH WHEN THIS ISSUE SHOULD RESOLVE. OMNIPOD ALSO DID NOT REPORT ISSUES PREVIOUSLY WITH SMART PUMP COMPATIBILITY WITH THE DEXCOM G7 AND USING THE IPHONE FOR THE CONTROLLER FOR THE PUMP. PATIENTS WHO HAD UPGRADED THEIR DEXCOM FROM THE G6 TO THE G7 WERE UNABLE TO UTILIZE AUTO MODE WITH THEIR IPHONE AS THE CONTROLLER AND NO ANNOUNCEMENT WAS MADE BY THE COMPANY REGARDING THIS, RESULTING IN PATIENT'S HAVING UNCONTROLLED BLOOD SUGARS FROM MANUAL MODE SETTINGS THAT ARE VASTLY DIFFERENT FROM WHAT THE AUTO MODE PUMP WOULD HAVE GIVEN THEM IF THEY WERE ABLE TO STAY IN AUTO MODE. OMNIPOD HAS BEEN NEGLIGENT IN NOTIFYING PATIENTS AND PRESCRIBERS OF THESE ISSUES WHEN THEY ARISE AND IT HAS THE POTENTIAL TO JEOPARDIZE PATIENT LIVES TO SEVERE HYPOGLYCEMIA OR SEVERE HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265260 GLOOKO MOBILE INSULIN DOSING SYSTEM CALCULATOR, DRUG DOSE NDC GLOOKO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other GLOOKO.