BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 25021836 · Received April 28, 2026

    Report

    Report Number
    3014585508-2026-23834
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 28, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_IOS. OMNIPOD SOFTWARE APP VERSION: 2.1.0. OPERATING SYSTEM: 26.3. HARDWARE: IPHONE15.4. CGM SENSOR TYPE: DATA NOT AVAILABLE. PLEASE NOTE, THE DEVICE IDENTIFIERS ARE CAPTURED AS REPORTED BY THE COMPLAINANT AND MAY NOT ALIGN WITH THE DEVICE CONFIGURATION REPORTED IN THIS SECTION AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT¿S BLOOD GLUCOSE (BG) LEVEL ROSE TO 380 MG/DL WHILE WEARING THE POD ON THEIR ARM FOR LONGER THAN 48 HOURS. THE PATIENT'S GRANDMOTHER REPORTED THAT WHILE PLAYING AT THE PLAYGROUND, THEY NOTICED THE POD ADHESIVE CAME OFF A LITTLE BIT. THE GRANDMOTHER STATED THEY PUSHED IT BACK, HOWEVER, DOES NOT KNOW IF THE CANNULA WAS SECURELY IN PLACE. THE GRANDMOTHER INDICATED THAT THE BG LEVELS HAVE BEEN GOING HIGH NUMEROUS TIMES AND IS NOT SURE IF THE FACT THEY HAD THAT INCIDENT ON THE PLAYGROUND COULD HAVE CAUSED THE HIGH BG LEVELS. AT THE TIME OF THE CALL THE POD WAS STILL IN PLACE, IT HAD NOT BEEN REMOVED. THERE WAS NO FURTHER INFORMATION PROVIDED. ADDITIONAL ATTEMPTS ARE BEING MADE TO REQUEST FURTHER DETAILS SURROUNDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12080 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1K10172531 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female