BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 15064460 · Received July 20, 2022

    Report

    Report Number
    3004464228-2022-12413
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    July 10, 2022
    Report Date
    July 15, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Product Problem
    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. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. 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 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 THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 20 MMOL/L (360 MG/DL) WHILE WEARING THE POD LONGER THAN 48 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE. THE PATIENT DEVELOPED AN INFECTION AT THE POD'S INSERTION SITE AND WAS TAKEN TO THE EMERGENCY ROOM. THE PATIENT WAS TREATED WITH INTRAVENOUS THERAPY AND WAS PRESCRIBED LUPIN-CEPHALEXIN (4 TIMES A DAY FOR 7 DAYS LIQUID ORAL USE). THE PATIENT WAS RELEASED AFTER 3 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648344 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 40160 L50273

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Required Intervention