BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 15472181 · Received September 23, 2022

    Report

    Report Number
    3004464228-2022-17633
    Event Type
    Injury
    Date Received
    September 23, 2022
    Date of Event
    September 20, 2022
    Report Date
    September 20, 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 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

    THE RETURNED DEVICE WAS EVALUATED AND THE INVESTIGATION RESULTS FOUND NO DAMAGES OR MANUFACTURING DEFICIENCIES THAT WOULD CAUSE THE REPORTED IRRITATION AT THE INFUSION SITE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. 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 PATIENT DEVELOPED SKIN IRRITATION, REDNESS, RAW SKIN, BLISTERS AND SCARRING WHILE WEARING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2837367 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 40160 L50342

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female