BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1941356 · Received December 21, 2010

    Report

    Report Number
    3004464228-2010-01445
    Event Type
    Other
    Date Received
    December 21, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 23, 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 WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WITHIN THE FIRST DAY OF WEARING THE POD, HE HAD "EXPERIENCED HIGH BLOOD SUGARS." HIS BG LEVEL WAS 73 MG/DL WHEN THE POD WAS FIRST APPLIED, BUT HAD RISEN TO 307 MG/DL DESPITE HAVING ADMINISTERED CORRECTION BOLUSES. A KINK WAS SEEN IN THE CANNULA, THOUGH, THE POD DID NOT INITIATE AN ALARM. THE POD WAS DISCARDED AND WILL THEREFORE, NOT 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 L30378

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other