BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1790055 · Received August 2, 2010

    Report

    Report Number
    3004464228-2010-01211
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    July 4, 2010
    Report Date
    July 5, 2010
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE PRODUCT USER GUIDE INSTRUCT 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. NOTE: BUILT INTO THE POD'S DESIGN ARE ELECTRICAL, MECHANICAL AND SOFTWARE SAFETY FEATURES THAT PREVENT THE DEVICE FROM OVER-DELIVERING INSULIN (WHICH COULD RESULT IN LOW BG LEVELS.)

    Description of Event or Problem · 1

    A NURSE PRACTITIONER CALLED TO REPORT THAT THE CUSTOMER BELIEVES "HER POD MAY HAVE GIVEN HER MORE INSULIN THAN WAS SUPPOSED TO BE GIVEN." THE CUSTOMER HAD TAKEN SICK AND, AS A RESULT, AN AMBULANCE WAS SENT TO HER HOME. IT IS UNKNOWN, HOWEVER, WHETHER SHE WENT TO THE HOSPITAL OR ER. THE NURSE PRACTITIONER, HOWEVER, WAS UNABLE TO PROVIDE DETAILED INFORMATION ABOUT THE POD OR PDM INVOLVED OR ABOUT THE EVENT. NO PRODUCT WILL 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 L30327

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention