BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3143086 · Received May 29, 2013

    Report

    Report Number
    3004464228-2013-00503
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 29, 2013
    Manufacturer
    INSULET CORPORTION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND HOSPITALIZATION. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. THE OMNIPOD USER GUIDE WARNS, "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL ABOVE 250 MG/DL. FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER." IT ADVISES, "IF YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE, CHECK FOR KETONES. IF KETONES ARE PRESENT, TAKE A CORRECTION BOLUS AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER. CHECK BLOOD GLUCOSE AGAIN AFTER 2 HOURS. IF BLOOD GLUCOSE LEVELS HAVE NOT DECREASED, TAKE A SECOND BOLUS BY INJECTION, USING A STERILE SYRINGE. IF BLOOD GLUCOSE REMAINS HIGH AFTER ANOTHER 2 HOURS (A TOTAL OF 4 HOURS), REPLACE THE POD."

    Description of Event or Problem · 1

    AT 11:00AM, WITH A BLOOD GLUCOSE RESULT OF 300 MG/DL, SHE WENT TO THE HOSPITAL, WHERE SHE RECEIVED INSULIN BY INTRAVENOUS DRIP. AT 12:54PM, HER RESULT WAS 304 MG/DL, AND AT 3:15PM, IT WAS 282 MG/DL. SHE THEN CHANGED THE POD. HER POD WAS DISCARDED AT THE HOSPITAL. SHE WAS RELEASED FROM THE HOSPITAL THE SAME DAY, AND WAS DOING BETTER AT THE TIME OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235145 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORTION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization