BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 19248389 · Received May 3, 2024

    Report

    Report Number
    MW5154536
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    April 18, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY SON'S OMNIPOD 5 CONTROLLER MALFUNCTIONED. IT HAD ME DISCARD 2 SEPARATE PODS, FULL OF INSULIN. I WAS THINKING MAYBE THE BOX OF PODS WERE DEFECTIVE. IT DID THE SAME THING WITH THE 3RD POD REPLACEMENT. THE CONTROLLER KEPT READING, DISCARD POD AND CAN'T BE ACTIVATED. I CALLED THE HELP LINE FOR OMNIPOD. FOR 1 AND A HALF HOURS, A CALL CENTER PERSON HELPED ME. WE HAD TO DEACTIVATE / CLEAR ALL INFO FROM THE CONTROLLER AND RESTART / REBOOT THE DEVICE. AS I WAS DINING MY SON TO SCHOOL AND DOSING HIM FOR THE BREAKFAST HE HAD EATEN; THE POD FLASHED A WARNING AND WOULDN'T DISTRIBUTE INSULIN, STATING IT WAS TOO MUCH. UPON LOOKING, THE CONTROLLER WAS GOING TO GIVE HIM 28 UNITS THAT WOULD HAVE KILLED HIM. I HAD TO DRIVE AN HOUR AWAY TO HIS DIABETES OFFICE AND HAVE THE DR RESET UP HIS CONTROLLER. MY SON MISSED SCHOOL THAT DAY. I AM NOW SUPER WORRY EVERY TIME I DEPEND ON HIS OMNIPOD TO DOSE. VERY SCARY EXPERIENCE FOR BOTH OF US. OMNIPOD CONTROLLER MALFUNCTION. REF REPORTS: MW5154534, MW5154535.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642676 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Required Intervention CHILDRENS DAILY VITAMIN GUMMY| HUMALOG| VITAMIN C DAILY GUMMY