BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2171914 · Received January 23, 2007

    Report

    Report Number
    3004464228-2007-00010
    Event Type
    Other
    Date Received
    January 23, 2007
    Date of Event
    December 24, 2006
    Report Date
    January 23, 2007
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS 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 REPORTED THAT SHE HAD EXPERIENCED UNEXPLAINED HIGH BLOOD GLUCOSE LEVELS USING A POD. AT THAT POINT, SHE REMOVED AND REPLACED HER POD AND DID NOT REPORT ANY FURTHER ISSUES. SHE REPORTED THAT WHEN SHE REMOVED THE POD, SHE NOTED THAT THE CANNULA APPEARED BENT. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED TO THE MFR FOR EVAL. SHE WAS UNABLE TO PROVIDE ANY LOT OR OTHER IDENTIFYING INFO FOR THE PRODUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other