BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 967103 · Received May 9, 2007

    Report

    Report Number
    3004464228-2007-00052
    Event Type
    Malfunction
    Date Received
    May 9, 2007
    Report Date
    May 9, 2007
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED FOR THE REPORTED PROBLEMS. IT WAS DETERMINED THAT THE NEEDLE MECHANISM DID NOT DEPLOY AND FULLY EXTEND THE CANNULA INTO THE SUBCUTANEOUS TISSUE. THIS WAS DUE TO A MANUFACTURING DEFECT. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO "CHECK INFUSION SITE FREQUENTLY FOR PROPER CANNULA PLACEMENT". IT ALSO SUGGESTS THAT THE USER SHOULD CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY, SO THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUE.

    Description of Event or Problem · 1

    CUSTOMER SAID SHE HAD A POD WHICH SHE DID NOT THINK WAS DELIVERIING INSULIN CORRECTLY. SHE ACTIVATED A NEW POD AT 11:05 P, AND HER BG WAS 242. SHE TOOK A BOLUS OF " AT LEAST 1 UNIT". ONE HOUR LATER, HER BG WAS 267, AND SHE TOOK ANOTHER 1.0U BOLUS. THREE HOURS AFTER THAT, HER BG WAS 228. AT THIS POINT, SHE THOUGH HER BG SHOULD HAVE DROPPPED MORE WITH THE BOLUSES, SO SHE REMOVED THE POD. SHE ACTIVATED A NEW POD SUCCESSFULLY, GAVE A 1.05U BOLUS, AND HER BG " DROPPED TO NORMAL BY MORNING." SHE SAID THE SITE (ON HER HIP) LOOKED OKAY, BUT DID NOT HAVE THE USUAL RED MARK SHE GETS AT THE CANNULA INSERTION SITE. SHE SAID THE CANNULA DID NOT LOOK BENT OR KINKED. SHE ACTIVATED ANOTHER POD AND NO FURTHER PROBLEMS WERE REPORTED. THE DEVICE IS BEING RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L10944

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other