BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3911552 · Received June 25, 2014

    Report

    Report Number
    3004464228-2014-00861
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 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 HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY DEFECT OR MANUFACTURING DEFICIENCY COULD HAVE CONTRIBUTED TO THE REPORTED ADHESION ISSUE AND THE PATIENT'S HOSPITALIZATION FOR HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POD ADHESIVE CAME LOOSE FROM THE SKIN. THE CUSTOMER WAS HOSPITALIZED FOR ONE DAY WITH HIGH (27.5 MMOL/L) BLOOD GLUCOSE LEVELS. SHE RECEIVED AN INFUSION WITH NACL AND NOVORAPID INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369702 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5J L40802

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization