BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2982219 · Received December 22, 2006

    Report

    Report Number
    3004464228-2006-00012
    Event Type
    Malfunction
    Date Received
    December 22, 2006
    Date of Event
    November 26, 2006
    Report Date
    December 22, 2006
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A MFG DEFECT CAUSED THE NEEDLE MECHANISM TO FAIL AND NOT PLACE THE CANNULA INTO THE PT¿S SUBCUTANEOUS TISSUE, RESULTING IN THE FAILURE OF THE DEVICE TO INFUSE INSULIN. IT APPEARS THAT THE PATIENT FAILED TO FOLLOW THE DEVICE INSTRUCTIONS FOR USE. 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.

    Description of Event or Problem · 1

    CUSTOMER SAID THAT THEY HAD TWO PODS WHICH THEY DID NOT THINK WERE DELIVERING INSULIN CORRECTLY. THE FIRST WAS DISCARDED AND THERE IS NO FURTHER INFO AVAILABLE. THE SECOND POD (LOT AND SEQUENCE NUMBERS NOTED) WAS RETURNED TO MFR FOR EVAL. THEY CHECKED THE PATIENT¿S BLOOD GLUCOSE AND IT WAS RUNNING ¿VERY HIGH¿ BUT SHE THOUGHT IT WAS DUE TO STRESS. WHEN SHE REMOVED THE POD, SHE NOTED THAT THE CANNULA MECHANISM HAD NOT DEPLOYED. NO FURTHER INFO WAS REPORTED. THE POD IS BEING RETURNED TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L10807

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR