BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3911562 · Received June 26, 2014

    Report

    Report Number
    3004464228-2014-00882
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 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 THE REPORTED HOSPITALIZATION. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE HAS BEEN HAVING ADHESIVE ISSUES WITH THE PRODUCT AND THAT SHE ENDED UP IN THE HOSP BECAUSE, SHE BELIEVES THAT THE POD WAS NOT DELIVERING INSULIN. NO FURTHER INFO REGARDING THE HOSPITALIZATION OR POSSIBLE TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373012 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization