BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3232265 · Received July 9, 2013

    Report

    Report Number
    3004464228-2013-00729
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 10, 2013
    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 RETURNED DEVICE WAS EVALUATED AND PERFORMED AS DESIGNED. NO MALFUNCTION OR OTHER PRODUCT CONDITION THAT COULD HAVE CONTRIBUTED TO THE PT'S HYPERGLYCEMIA AND HOSPITALIZATION WAS FOUND. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA)," AND ADVISES "IF YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE, CHECK FOR KETONES. IF KETONES ARE PRESENT, FOLLOW YOUR HEALTHCARE PROVIDER'S GUIDELINES. IF KETONES ARE NOT 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

    THE PT REPORTED THAT ON (B)(6) HER BLOOD GLUCOSE MEASURED 500 MG/DL AT BOTH 2:29 PM AND 12:21 PM. SHE CORRECTED WITH A 20 UNIT BOLUS BOTH TIMES (TOTAL OF 40 UNITS). SHE DEACTIVATED THE POD AT 7:43 PM AND WENT TO THE HOSPITAL BECAUSE OF HER HYPERGLYCEMIA. THEY MEASURED HER BG AT >600 MG/DL. SHE DOES NOT KNOW EXACTLY WHAT HAPPENED AT THE HOSP, BUT SHE HAD A HEART MONITOR, BLOOD PRESSURE CUFF AND INSULIN DRIP. SHE REMAINED HOSPITALIZED FOR FOUR DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312695 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31068

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization