BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 21525797 · Received March 5, 2025

    Report

    Report Number
    3004464228-2025-09275
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 17, 2025
    Report Date
    March 5, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000022
    PMA / PMN Number
    K203768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED LDC SCREEN EVENT NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. ON PAGE 468 OF THE OMNIPOD® 5 AUTOMATED INSULIN DELIVERY SYSTEM TECHNICAL USER GUIDE REFERENCE #: PDM-H001-G-MG PT-002111-AW REV. 02 10/24. CONTROLLER SPECIFICATIONS OPERATING TEMPERATURE RANGE: 41°F TO 104°F (5°C TO 40°C) STORAGE TEMPERATURE RANGE: 32°F TO 86°F (0°C TO 30°C). *PLEASE NOTE, THAT SECTION D IS CAPTURING THE DEVICE IDENTIFIERS AS REPORTED BY THE COMPLAINANT. THIS MAY NOT ALIGN TO THE DEVICE CONFIGURATION REPORTED IN H11, AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT. CLOUD - LOCKED DOWN/SMARTPHONE LOCKDOWN CLOUD - OMNIPOD 5 SOFTWARE APP VERSION 3.1.1 CLOUD - SMARTPHONE OPERATING SYSTEM N5004L-AM-Q-MV01602-06-01.06 CLOUD - SMARTPHONE HARDWARE N5004L CLOUD - CGM SENSOR TYPE.

    Description of Event or Problem · 0

    PATIENT ALLEGED HIS PDM WAS IN HIS POCKET WHEN HE WAS OUTSIDE IN THE COLD TEMPERATURE OF 28°F, AND WHEN HE RETURNED IN HIS WARM HOUSE, THE PDM SCREEN EXPLODED AND CAUSED SMALL PIECES OF THE LENS TO GO INTO HIS HANDS. NO IMPACT TO PATIENT'S BLOOD GLUCOSE LEVELS REPORTED. NO MEDICAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474229 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-001827 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male