BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1170349 · Received September 9, 2008

    Report

    Report Number
    3004464228-2008-00201
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 11, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED AND IT WAS DETERMINED THAT THE SOFT CANNULA WAS NOT INSTALLED CORRECTLY, PREVENTING THE CANNULA FROM PENETRATING THE SKIN. 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 THAT THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. THE PATIENT REMEDIED THE SITUATION BY REMOVING AND REPLACING THE DEVICE PER USER INSTRUCTIONS. THE LOT WAS FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING THAT SHE HAD HIGH BLOOD GLUCOSE LEVELS (BG'S) ALL DAY. WHEN SHE TOOK THE POD OFF, SHE NOTICED THE CANNULA DID NOT COME OUT OF THE POD AND INTO HER SKIN. CUSTOMER WAS ABLE TO ACTIVATE A NEW POD SUCCESSFULLY. A FOLLOW-UP CALL WITH CUSTOMER CONFIRMED HER BG'S WERE COMING DOWN WITH THE NEW POD ON. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11809

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other