BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 4258846 · Received November 13, 2014

    Report

    Report Number
    3004464228-2014-01729
    Event Type
    Injury
    Date Received
    November 13, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. NO LOT QUALIFICATION OR STERILIZATION RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    INSULET CORPORATION RECEIVED AN EMAIL FROM GEFFEN MEDICAL STATING THAT THE CUSTOMER HAD AN INFECTION. NO FURTHER DETAIL WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733862 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other