BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 15552452 · Received October 6, 2022

    Report

    Report Number
    3004464228-2022-18692
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    September 28, 2022
    Report Date
    September 29, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120057
    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

    CORRECTION TO D4: CATALOG NO CHANGED FROM UNAVAILABLE TO ZXP425. CORRECTION TO G5: PMA/510(K) # CHANGED FROM UNAVAILABLE TO K192659.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE A PATIENT HAD BEEN WEARING A POD BETWEEN 4 AND 24 HOURS THEIR BLOOD GLUCOSE LEVEL HAD ROSE TO OVER 301 MG/DL. THE PATIENT REPORTS THE POD WAS LEAKING DURING WEAR AND THEY EXPERIENCED IRRITATION AT THE POD INFUSION SITE, (ARM). AS TREATMENT, THE PATIENT WAS PRESCRIBED A CREAM FOR THE IRRITATION AT THE POD INFUSION SITE. THE POD WILL NOT BE RETURNED AS IT HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288386 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18025 L72356 20385081120057

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Required Intervention