BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 23955949 · Received January 5, 2026

    Report

    Report Number
    3014585508-2026-00238
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    December 7, 2025
    Report Date
    January 5, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. LOCKED DOWN SMARTPHONE: NOT REPORTED. OMNIPOD SOFTWARE APP VERSION: NOT REPORTED. OPERATING SYSTEM: NOT REPORTED. HARDWARE: NOT REPORTED. CGM SENSOR TYPE: NOT REPORTED. 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.

    Additional Manufacturer Narrative · 0

    UPDATED B5 TO INCLUDE REPORT THAT CANNULA WAS BENT. ADDED H6 MEDICAL DEVICE PROBLEM CODE A040609 MATERIAL TWISTED/BENT. ADDED H6 COMPONENT CODE G04019 CANNULA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT CONTACTED MEDICAL PROFESSIONAL ON (B)(6) 2025 DUE TO HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED GREATER THAN 600 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED THAT HER GLUCOSE MONITOR AND POD WERE NOT CONNECTING AND THEREFORE SHE WAS NOT RECEIVING ACCURATE BLOOD GLUCOSE READINGS. ADDITIONALLY, THE POD WAS LEAKING AND PATIENT FELT PAIN WHEN TRYING TO BOLUS. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA, VOMITING, AND ¿HEAVY BRAIN¿. THE PATIENT WAS INSTRUCTED BY NURSE TO CHANGE THEIR POD, CHECK GLUCOSE LEVELS WITH A METER AND DRINK PLENTY OF FLUIDS, TO AVOID GOING INTO A COMA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT CONTACTED MEDICAL PROFESSIONAL ON (B)(6) 2025 DUE TO HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED GREATER THAN 600 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED THAT HER GLUCOSE MONITOR AND POD WERE NOT CONNECTING AND THEREFORE SHE WAS NOT RECEIVING ACCURATE BLOOD GLUCOSE READINGS. ADDITIONALLY, THE POD WAS LEAKING, CANNULA WAS BENT, AND PATIENT FELT PAIN WHEN TRYING TO BOLUS. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA, VOMITING, AND ¿HEAVY BRAIN¿. THE PATIENT WAS INSTRUCTED BY NURSE TO CHANGE THEIR POD, CHECK GLUCOSE LEVELS WITH A METER AND DRINK PLENTY OF FLUIDS, TO AVOID GOING INTO A COMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19476 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1K12142441 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female