BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1366008 · Received January 23, 2009

    Report

    Report Number
    3004464228-2009-00043
    Event Type
    Other
    Date Received
    January 23, 2009
    Date of Event
    December 28, 2008
    Report Date
    December 28, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE CUSTOMER STATED THAT A KINK WAS NOTED IN THE CANNULA. THERE WAS NO REPORT OF AN ALARM; HOWEVER, THE POD WOULD HAVE INITIATED AN OCCLUSION ALARM IF THE FLOW OF INSULIN WAS RESTRICTED/PREVENTED BY THE KINK AND RESULTED IN BACK PRESSURE. 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 PT REMEDIED THE SITUATION BY REMOVING AND REPLACING THE DEVICE PER USER INSTRUCTIONS.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER CALLED TO SAY THAT THIS POD WAS PLACED ON HIM AT BED TIME AND WHEN HE WOKE UP HIS BLOOD GLUCOSE (BG) WAS 438 MG/DL. WHEN THE CUSTOMER'S MOTHER REMOVED THE POD SHE THOUGHT THE CANNULA WAS BENT/KINKED AND HAD BLOOD IN IT. THE POD WAS REMOVED AND IS NOT BEING RETURNED. NO FURTHER ISSUES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30062

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other