BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 15496285 · Received September 28, 2022

    Report

    Report Number
    3004464228-2022-17948
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    September 20, 2022
    Report Date
    September 21, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED ER VISIT. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D(4): CATALOG NO CHANGED FROM UNAVAILABLE TO ZXP425. CORRECTION TO G(5): PMA/510(K) # CHANGED FROM UNAVAILABLE TO K192659.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT VISITED THE EMERGENCY ROOM (ER) DUE TO EXCESSIVE BLEEDING, AFTER REMOVING THE POD THAT EMITTED AN OCCLUSION ALARM AND WAS WORN ON THE ABDOMEN BETWEEN 1 AND 4 HOURS. AT THE HOSPITAL, THE PATIENT WAS PLACED ON AN IV (UNSPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635475 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 40160 L50295

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention| H