BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3131374 · Received May 13, 2013

    Report

    Report Number
    3004464228-2013-00432
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 13, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE REPORTED RUSTED CONDITION OF THE INSERTION NEEDLE. NO PRODUCT LOT NUMBER WAS REPORTED, THEREFORE NO REVIEW OF QUALIFICATION AND STERILIZATION RECORDS COULD BE COMPLETED. THE OMNIPOD USER GUIDE WARNS "DO NOT APPLY OR USE A POD IF IT IS DAMAGED IN ANY WAY. A DAMAGED POD MAY NOT WORK PROPERLY," AND NOTES "WHEN YOU REMOVE THE NEEDLE CAP, A FEW DROPS OF INSULIN SHOULD BE VISIBLE AT THE END OF THE NEEDLE."

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT HER DAUGHTER WAS HOSPITALIZED FOR A SEVERE SKIN INFECTION AND HAD BEEN RELEASED ABOUT TWO AND A HALF WEEKS PRIOR TO HER CALL. SHE STATED THAT THE NEEDLE WAS RUSTY IN THE POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212148 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization