BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3894085 · Received June 19, 2014

    Report

    Report Number
    3004464228-2014-00837
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION TO HAVE CONTRIBUTED TO THE PATIENT'S KETOACIDOSIS AND HOSPITALIZATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    AN EMAIL COMMUNICATION FROM (B)(6) WAS RECEIVED TO REPORT A (B)(6) BOY THAT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THERE WAS NO CARBOHYDRATE COUNT PROVIDED. HE WAS TAKEN TO THE HOSPITAL WHERE THEY TESTED HIS KETONES AND THEY WERE HIGH. HE WAS DIAGNOSED FOR DIABETIC KETOACIDOSIS AND HE WAS TREATED WITH MANUAL INJECTION OF INSULIN. HE WAS RELEASED FROM THE HOSPITAL LATER THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361807 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40927

    Patients

    Seq Age Sex Outcome Treatment
    1 114 YR Hospitalization