BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1952947 · Received January 4, 2011

    Report

    Report Number
    3004464228-2011-00004
    Event Type
    Other
    Date Received
    January 4, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 7, 2010
    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 POD WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE CUSTOMER STATED THAT A KINK WAS SEEN IN THE CANNULA. THERE WAS, HOWEVER, NO REPORT OF AN OCCLUSION ALARM. 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 OMNIPOD 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 IN ORDER TO 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

    THE CUSTOMER REPORTED THAT SHE HAD EXPERIENCED "HIGH" BG LEVELS (GREATER THAN 500MG/DL) WITHIN THE FIRST FOUR HOURS OF WEARING THE POD. MULTIPLE CORRECTION BOLUSES HAD BEEN ADMINISTERED, BUT WERE INEFFECTIVE IN LOWERING HER BG'S. THE CANNULA WAS REPORTEDLY KINKED, THOUGH THE POD DID NOT INITIATE AN ALARM. THE POD WAS DEACTIVATED AND WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30339

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other