BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3940844 · Received July 7, 2014

    Report

    Report Number
    3004464228-2014-00946
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    INSULET CORP
    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 THE BENT CANNULA OR TO DETERMINE IF THERE ARE ANY PRODUCT MALFUNCTIONS THAT COULD HAVE CONTRIBUTED TO THE PT'S KETOACIDOSIS AND HOSPITALIZATION.

    Description of Event or Problem · 1

    AN INSULET TERRITORY MANAGER REPORTED THAT AN OMNIPOD PT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND ALSO STATED THAT THE CANNULA WAS BENT. NO FURTHER INFORMATION REGARDING HER BLOOD GLUCOSE HISTORY, HOSPITALIZATION OR HER TREATMENT WAS PROVIDED. ATTEMPTS WERE MADE TO CONTACT THE PT'S PARENTS TO PROVIDE ADDITIONAL INFORMATION. MESSAGES WERE LEFT, BUT THEY DID NOT RETURN THE CALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393282 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORP 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization