BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 15234464 · Received August 16, 2022

    Report

    Report Number
    3004464228-2022-14740
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    August 6, 2022
    Report Date
    August 12, 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

    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 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 THAT THE PATIENT WENT TO THEIR DOCTOR AND WAS DIAGNOSED WITH A BACTERIAL INFECTION. FOR TREATMENT, THE PATIENT WAS PRESCRIBED SULFAMETHOXAZOLE AT 2 TIMES PER DAY FOR 7 DAYS AND THE SITE WAS DRAINED. THE PATIENT WAS ADVISED TO TAKE TRAMADOL AT 50 MG STRENGTH. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON UNKNOWN LOCATION. THE PATIENT WAS DISCHARGED AFTER 1 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916852 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18025 L71335 20385081120057

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention