BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3853476 · Received May 28, 2014

    Report

    Report Number
    3004464228-2014-00722
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 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 CONFIRM ANY PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION TO HAVE CONTRIBUTED TO THE PATIENT'S KETOACIDOSIS AND HOSPITALIZATION. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO QUALIFICATION RECORDS WERE REVIEWED.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT ABOUT 3 WEEKS AGO ON FRIDAY EVENING HER DAUGHTER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. SHE STAYED AT THE HOSPITAL FOR A DAY BEFORE BEING RELEASE. SHE DID NOT PROVIDE ANY FURTHER INFORMATION REGARDING THE HOSPITALIZATION, BG HISTORY OR HER DAUGHTER'S TREATMENT. ATTEMPTS WERE MADE TO CONTACT THE PATIENT'S MOTHER TO PROVIDE ADDITIONAL INFORMATION. MESSAGES WERE LEFT, BUT SHE DID NOT RETURN THE CALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312846 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization