BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1050236 · Received May 23, 2008

    Report

    Report Number
    3004464228-2008-00075
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 25, 2008
    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. UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION NO CONCLUSION CAN BE REACHED AT THIS TIME. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES.

    Description of Event or Problem · 1

    FATHER CALLED FOR DAUGHTER AFTER SHE WAS ADMITTED TO THE HOSPITAL WITH HIGH BG LEVEL'S. CUSTOMER PLACED THE POD IN 2008 AT BREAKFAST. BY THAT EVENING, SHE WAS ADMITTED TO THE ER WITH BG'S IN THE HIGH 400'S. ONCE ADMITTED THE POD WAS REMOVED AND SHE WAS PLACED ON AN INSULIN DRIP WHERE BG WAS LOWERED TO 121. WHEN POD WAS REMOVED, FATHER STATED THERE "WAS BLOOD INSIDE THE POD" HOWEVER, THEY RECEIVED NO ALARMS WITH THE SYSTEM. FATHER STATED THAT BEFORE THIS INCIDENT HIS DAUGHTER HAD BEEN INTOUCH WITH HER DOCTOR TO READJUST HER BASAL RATES AS SHE HAD BEEN RUNNING AT A CONSISTENT RANGE OF ABOUT 200. THE DAY SHE WAS ADMITTED CUSTOMER DELIVERED RECOMMENDED BOLUSES YET THE BG CONTINUED TO RAISE. NO LOT OR SEQ ID INFO COULD BE GATHERED SINCE THE POD IN QUESTION WAS THROWN OUT WHEN THEY ARRIVED AT THE HOSPITAL WHERE IT WAS REMOVED. NO FURTHER INFORMATION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention