BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1882294 · Received October 20, 2010

    Report

    Report Number
    3004464228-2010-01322
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD INVOLVED WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO INFORMATION ABOUT THE CUSTOMER'S HOSPITALIZATION OR THE POD INVOLVED WAS PROVIDED. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE OMNIPOD USER GUIDE INSTRUCTS USERS TO CHECK BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT THEY'RE ABLE TO NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. THE USER GUIDE ALSO SUGGESTS THAT THE PATIENT ALWAYS CARRY EXTRA SUPPLIES IN CASE OF AN EMERGENCY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS PLACED IN THE ICU FOR NINE DAYS BECAUSE THE POD "STOPPED WORKING". NO SPECIFIC DEVICE FAILURE WAS REPORTED, BUT DOCTORS INDICATED THAT THE POD HAD "MALFUNCTIONED." NO DETAILS ABOUT THE EVENT OR THE DEVICE WERE PROVIDED. ATTEMPTS TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE POD WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization