BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1211582 · Received October 23, 2008

    Report

    Report Number
    3004464228-2008-00263
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 24, 2008
    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 DEVICE INVOLVED WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT INFORMATION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY, SO THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES. IT ALSO SUGGESTS THAT THE PATIENT ALWAYS CARRY EXTRA SUPPLIES IN CASE OF EMERGENCY.

    Description of Event or Problem · 1

    WIFE CALLED FOR HUSBAND TO REPORT A POD THAT THEY DID NOT FEEL WAS DELIVERING INSULIN AND AS A RESULT, THE CUSTOMER ENDED UP IN THE ER WITH ELEVATED BLOOD GLUCOSE LEVELS (BG'S). CUSTOMER PLACED THE POD IN 2008. CUSTOMER WENT THROUGH THE DAY WITHOUT ISSUE, BUT BY DINNER TIME HIS BG HAD RISEN TO 400 MG/DL. AT THIS TIME, HE DELIVERED A 30 UNIT BOLUS OF INSULIN TO CORRECT THE BG. SYSTEM DELIVERED BOLUS WITH NO INDICATION OF AN ERROR. BY BEDTIME, THE CUSTOMER'S BD READ HIGH ON THE PDM SCREEN. AGAIN HE DELIVERED A 30 UNIT BOLUS. CUSTOMER WENT TO BED AND BY 3 AM CUSTOMER'S WIFE CALLED AMBULANCE TO BRING HIM TO THE ER. POD WAS REMOVED AT THE ER AND DISCARDED; THEREFORE, NO POD LOT INFORMATION CAN BE NOTED. WHEN BG LEVEL WAS TAKEN AT THE ER, IT REGISTERED AT 1100 MG/DL. CUSTOMER WAS PLACED ON IV INSULIN ALONG WITH OTHER IV DRUGS TO DEAL WITH DEHYDRATION. WHEN POD WAS REMOVED, THE CANNULA WAS NOT COMPROMISED NOR DID THE SITE LOOK IRRITATED. SINCE POD WAS REMOVED AT ER, IT WAS NOT SAVED AND THERE WAS NO WAY TO RETRIEVE IT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention