BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2221619 · Received August 19, 2011

    Report

    Report Number
    3004464228-2011-00447
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 25, 2011
    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 WILL NOT BE RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM ANY DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS, LEADING TO HOSPITALIZATION. NO SPECIFIC FAILURE MODE WAS NOTED IN THE REPORT. BASED ON THE INFO PROVIDED AND IN THE ABSENCE OF A DEVICE EVAL, WE CANNOT CONCLUDE THAT A POD MALFUNCTION WAS A CONTRIBUTING FACTOR TO THE EVENT. NO CONCLUSION CAN BE DRAWN. THE CUSTOMER STATED THAT "THE POD WAS EXPOSED TO PERIODS IN THE SUN" (THOUGH SPECIFIC TEMPERATURE READINGS WERE NOT PROVIDED). THE OMNIPOD USER GUIDE CONTAINS THE FOLLOWING WARNING." DO NOT EXPOSE A POD TO DIRECT SUNLIGHT FOR LONG PERIODS OF TIME. IT IS RECOMMENDED THAT YOU REMOVE YOUR POD PRIOR TO USING HOT TUBS, WHIRLPOOLS OR SAUNAS. THESE CONDITIONS COULD EXPOSE THE POD TO EXTREME TEMPERATURES AND MAY ALSO AFFECT THE INSULIN INSIDE THE POD." THE USER GUIDE FURTHER NOTES THAT "INSULIN DEGRADES AT HIGH TEMPERATURES". THE POD'S OPERATING TEMPERATURE IS BETWEEN 40 AND 104 -DEGREES F. THOUGH IT CANNOT BE CONFIRMED, IT IS POSSIBLE THAT THE EXPOSURE OF THE POD TO HIGH TEMPERATURES FROM THE SUN MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE CUSTOMER'S HYPERGLYCEMIC EVENT. A REVIEW OF LOT QUALIFICATION RECORDS WAS PERFORMED. THE LOT PASSED THE ACCEPTANCE CRITERIA. NOTE: EVAL METHOD CODES ARE SPECIFIC TO ACTIVITIES PERFORMED DURING LOT QUALIFICATION, AND NOT TO ACTIVITIES PERFORMED ON THE SUBJECT POD (AS IT WAS NOT RETURNED FOR EVAL).

    Description of Event or Problem · 1

    AFTER WEARING THE POD FOR TWO DAYS, THE CUSTOMER EXPERIENCED HIGH BG LEVELS "ABOVE 600MG/DL" WHICH REQUIRED HER TO BE HOSPITALIZED. SHE WAS ON A BEACH VACATION AT THE TIME "AND WAS EXPOSED TO PERIODS IN THE SUN" DURING THE TRIP. HER BG'S ABOUT THREE HOURS INTO THE TRIP WERE 129MG/DL, BUT SHE "BEGAN TO FEEL NAUSEATED AND FELT HEARTBURN AND HEART PALPITATIONS." HER DOCTOR SAID THAT THE "INSULIN MAY HAVE BEEN AFFECTED BY BEING EXPOSED TO THE SUN FOR LONG PERIODS OF TIME." SHE LEFT THE HOSPITAL AFTER APPROX EIGHT HOURS (THE TREATMENT SHE RECEIVED WHILE IN THE HOSPITAL WAS NOT PROVIDED). SINCE THIS EVENT, SHE HAS GONE BACK ON THE POD AND "HAS NOT HAD ANOTHER HIGH BG EVENT." IN ADDITION, PRIOR TO THIS INCIDENT SHE "HAS NOT HAD A PREVIOUS HIGH BG EVENT." THE DEVICE WAS DISCARDED AT THE HOSPITAL AND WILL THEREFORE NOT BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30526

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization