BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1081644 · Received July 23, 2008

    Report

    Report Number
    3004464228-2008-00141
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT 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

    CUSTOMER WAS ON A CANOEING/CAMPING TRIP FOR THE WEEKEND. SHE CHECKED HER BG IN THE MORNING BEFORE THEY STARTED CANOEING AND IT WAS 80MG/DL. SHE HAD BEEN WEARING THE POD ON HER ABDOMEN FOR ABOUT A DAY AT THIS POINT. SHE SAID SHE ATE AND BOLUSED DURING THE DAY, BUT DID NOT CHECK HER BG UNTIL 8 PM, AND IT WAS "ABOVE 400". SHE INITIATED A BOLUS, BUT BY MIDNIGHT SHE WAS VOMITING AND FELT VERY SICK. SHE CHECKED AGAIN, AND HER BG HAD RISEN TO 437 MG/DL. SHE KEPT THE POD ON AND DID NOT TRY TO CHANGE IT UNTIL THE MORNING. SHE HAD ONLY BROUGHT ONE BACKUP POD WITH HER AND NO BACKUP VIAL OF INSULIN, OR SYRINGES AS "EVERYONE WAS TRYING TO PACK LIGHTLY". WHILE PRIMING, THE POD ALARMED. AT THIS POINT, SHE HAD BEEN VOMITING ALL NIGHT. THEY SET OUT ON THE CANOE, AND CANOED FOR TWO HOURS. THEY FOUND A HOUSE ON THE RIVER, FROM WHICH THEY CALLED AN AMBULANCE. SHE SAID THAT SHE WAS TAKEN BY AMBULANCE FROM THERE TO A HOSPITAL, WHERE SHE WAS ADMITTED FOR DKA. SHE SAID, SHE STAYED AT THE HOSPITAL OVERNIGHT. WHEN SHE HAD REMOVED THE FIRST POD, SHE SAID THAT SHE NOTICED THE CANNULA WAS BENT. SHE SAID THAT HER HUSBAND HAD CHECKED THE SITE DURING THE NIGHT, AND COULD NOT SEE WHETHER THE CANNULA WAS IN HER SKIN OR NOT, THOUGH HE THOUGHT THAT IT WAS IN. SHE SAID THAT THE SITE WAS "A BIT RED" WHEN SHE REMOVED THE POD. SHE STATED THAT SHE NO LONGER HAD THE POD AT THE TIME OF THE CALL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11489

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization