BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 814630 · Received February 6, 2007

    Report

    Report Number
    3004464228-2007-00016
    Event Type
    Other
    Date Received
    February 6, 2007
    Date of Event
    January 7, 2007
    Report Date
    February 6, 2007
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE DISCARDED SO NO DEVICE EVAL IS POSSIBLE. NO CONCLUSION CAN BE DRAWN. DEVICE LABELING INSTRUCTS THE USER TO VERIFY PROPER PLACEMENT OF THE CANNULA AND CHECK THE SITE FREQUENTLY TO VERIFY AND INSURE PROPER CANNULA PLACEMENT AT THE INFUSION SITE.

    Description of Event or Problem · 1

    THE PT'S MOTHER CALLED AND REPORTED THAT HER SON HAD EXPERIENCED UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS AND SYMPTOMS OF DKA AFTER ACTIVATING THREE PODS. SHE STATED THAT IT APPEARED THE PODS WERE LEAKING AT THE INSERTION SITE. AT THAT POINT HE DECIDED TO GO TO THE ER FOR TREATMENT. DURING A F/U CALL THE NEXT DAY, THE PT REPORTED THAT WHEN HE REMOVED THE POD HE WAS USING WHEN HIS BG LEVELS ROSE HE NOTICED THAT THE CANNULA HAD COME OUT OF THE SKIN, WHICH IS WHERE THE INSULIN WAS LEAKING FROM. THE PT HAD REMOVED AND REPLACED THE POD AND DID NOT REPORT ANY FURTHER ISSUES. THE DEVICES INVOLVED WERE DISCARDED AND WILL NOT BE RETURNED TO THE MFR FOR EVAL. HE WAS UNABLE TO PROVIDE ANY LOT OR OTHER IDENTIFYING INFO FOR THE PRODUCTS INVOLVED.

    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 15 YR Other