BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1441649 · Received March 11, 2009

    Report

    Report Number
    3004464228-2009-00168
    Event Type
    Other
    Date Received
    March 11, 2009
    Date of Event
    February 13, 2009
    Report Date
    February 13, 2009
    Manufacturer
    INSULET CORP
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT HAS NOT BEEN RETURNED TO THE MFR 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 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 CALLED TO SAY THAT SHE DID NOT THINK HER POD WAS WORKING PROPERLY. CUSTOMER STATED THAT WHEN SHE REMOVED THE POD THE CANNULA WAS VERY BENT. THE CUSTOMER'S BLOOD GLUCOSE LEVELS FLUCTUATED BETWEEN 223-313 MG/DL WHILE WEARING THIS POD. SHE WAS ABLE TO ACTIVATE A NEW POD SUCCESSFULLY. 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 CORP 11200 L30063

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other