BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 13699272 · Received March 8, 2022

    Report

    Report Number
    3004464228-2022-04031
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    March 3, 2022
    Report Date
    March 5, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    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

    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 SKIN IRRITATION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD IS ISO10993 COMPLIANT, UNDERGOING CYTOTOXICITY, SENSITIZATION, GENOTOXICITY, HEMOLYSIS, IRRITATION OR INTRACUTANEOUS REACTIVITY, SYSTEMIC TOXICITY, AND IMPLANTATION EFFECTS TESTING. THE OMNIPOD IS STERILIZED WITH 100% ETHYLENE OXIDE GAS WITH A STERILITY ASSURANCE LEVEL OF 10-6  PER ISO11135  AND EO RESIDUAL LEVELS IN COMPLIANCE WITH ISO10993. EACH LOT  IS CONFIRMED TO MEET REQUIREMENTS FOR NON-PYROGENICITY PER ISO10993 AND STERILITY PER ISO11135 PRIOR TO RELEASE.

    Additional Manufacturer Narrative · 0

    ADD TO EMDR-98423 HEALTH EFFECT - CLINICAL CODE = E231501 PURULENT DISCHARGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WENT TO THEIR DOCTOR AND WAS DIAGNOSED WITH A SKIN IRRITATION. THERE WAS PURULENT DISCHARGE. FOR TREATMENT, THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE POD WAS WORN LONGER THAN 48 HOURS ON THE LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856565 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L71239 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention