BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 24876431 · Received April 14, 2026

    Report

    Report Number
    3014585508-2026-20398
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    March 1, 2026
    Report Date
    April 14, 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

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4, G4: PT101EW IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA (PT101US). THE 510(K) FOR THE SIMILAR PRODUCT IS K131895. FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY IN THE PROCESS OF COMPLETING F&P'S INVESTIGATION. F&P WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF F&P'S INVESTIGATION. PRODUCT BACKGROUND: THE PT101 AIRVO 2 HUMIDIFIER (AIRVO 2) IS AN ACTIVE HUMIDIFIER WITH INTEGRATED FLOW GENERATOR THAT DELIVERS HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES TO SPONTANEOUSLY BREATHING PATIENTS THROUGH A VARIETY OF PATIENT INTERFACES. ITS INTENDED USE IS FOR THE TREATMENT OF SPONTANEOUSLY BREATHING PATIENTS WHO WOULD BENEFIT FROM RECEIVING HIGH FLOW WARMED AND HUMIDIFIED RESPIRATORY GASES. THE AIRVO 2 IS NOT INTENDED FOR LIFE SUPPORT, AND APPROPRIATE PATIENT MONITORING MUST BE USED AT ALL TIMES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT¿S BLOOD GLUCOSE LEVELS INCREASED TO ABOVE 600 MG/DL AFTER APPROXIMATELY 24 TO 36 HOURS OF POD WEAR ON THE ARM. THE PATIENT NOTED THAT THE POD EMITTED A HAZARD ALARM INDICATING INSULIN DELIVERY HAD STOPPED; HOWEVER, BY THE TIME THE POD WAS REPLACED, BLOOD GLUCOSE LEVELS WERE ELEVATED AND THE PATIENT DEVELOPED SYMPTOMS INCLUDING VOMITING, DIARRHEA, AND BODY SORENESS. BLOOD GLUCOSE LEVELS WERE DISPLAYED AS "HIGH" IN THE OMNIPOD SYSTEM, INDICATING LEVELS GREATER THAN 400 MG/DL. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL, WHERE THEY WERE DIAGNOSED WITH HYPERGLYCEMIA AND A POTASSIUM IMBALANCE. TREATMENT DURING HOSPITALIZATION INCLUDED INSULIN THERAPY AND PAIN MEDICATION, WITH A COMPUTED TOMOGRAPHY (CT) SCAN AND ULTRASOUND ALSO CONDUCTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2026. THE POD WAS DISCARDED AT THE HOSPITAL SO IT IS UNAVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324242 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1U07182511 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Hospitalization