BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 931447 · Received October 23, 2007

    Report

    Report Number
    3004464228-2007-00136
    Event Type
    Other
    Date Received
    October 23, 2007
    Report Date
    October 23, 2007
    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 EVALUATED FOR DAMGE AND/OR DEFECTS RELATED TO MANUFACTURING. NONE WERE NOTED. THE POD WAS TESTED FOR FLOW AND FLUID WAS OBSERVED EXITING THE DISTAL TIP OF THE CANNULA. THIS DEMONSTRATED THE POD WAS NOT OCCLUDED INTERNALLY. THE CANNULA WAS FULLY DEPLOYED AS RECEIVED FOR EVALUATION. NO EVIDENCE OF INTERNAL INSULIN LEAKAGE WAS FOUND INSIDE THE POD. THE NEEDLE MECHANISM WAS FOUND TO FUNCTION AS INTENDED WITH NO EVIDENCE OF ANY DAMAGE OR MANUFACTURING DEFICIENCY THAT MIGHT HAVE DELAYED NEEDLE INSERTION. IT IS UNK WHY THE USER EXPERIENCED HIGH BLOOD GLUCOSE LEVEL'S. A REVIEW OF THE DHR FOR THIS LOT NUMBER DOES NOT SHOW ANY ABNORMAL EVENTS OR TRENDS FROM MANUFACTURING AND TESTING. THE LOT WAS FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO "CHECK INFUSION SITE FREQUENTLY FOR PROPER CANNULA PLACEMENT." IT ALSO SUGGEST, THAT THE USER SHOULD CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT HIGH BLOOD SUGAR LEVELS AND DKA AND WAS HOSPITALIZED FOR 1 NIGHT. SHE SAID, SHE IS PINCHING UP SOME FAT AROUND THE INFUSION SITE AND THERE IS NO PAIN. NO PROBLEMS WERE NOTED WITH THE DEVICE. NO FURTHER INFORMATION REPORTED. THE DEVICE 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 L11232

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization