BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1613176 · Received February 12, 2010

    Report

    Report Number
    3004464228-2010-01046
    Event Type
    Other
    Date Received
    February 12, 2010
    Date of Event
    January 14, 2010
    Report Date
    January 15, 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 PRODUCT WAS NOT RETURNED TO THE MANUFACTURER 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, 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. NOTE: THE POD HISTORY INDICATES THAT THE DEVICE INITIATED AN ALARM AT THE END OF ITS OPERATION. THE SPECIFIC TYPE OF ALARM, HOWEVER, IS NOT KNOWN SINCE THE DEVICE WAS NOT RETURNED FOR EVAL. 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 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 REPORT INDICATED THAT THE CUSTOMER EXPERIENCED SPORADIC HIGH BGS (298-323MG/DL) OVER THE 14 HOURS FOLLOWING THE ACTIVATION OF A NEW POD. THE CANNULA WAS NOTED AS BEING KINKED, THOUGH NO OCCLUSION ALARM WAS SPECIFICALLY REPORTED. IT SHOULD BE NOTED THAT THE POD DID INITIATE AN ALARM AT THE END OF ITS OPERATION, BUT THE SPECIFIC ALARM TYPE IS UNK. SINCE THE POD WAS NOT RETURNED FOR EVAL, IT IS UNK WHETHER THE ALARM WAS INITIATED IN RESPONSE TO THE KINK IN THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30231

    Patients

    Seq Age Sex Outcome Treatment
    1 35 MO Other