BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3131543 · Received May 16, 2013

    Report

    Report Number
    3004464228-2013-00453
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY MALFUNCTION OR OTHER PRODUCT CONDITION. THE CUSTOMER REPORTED THAT THE CANNULA WAS NOT IN THE INFUSION SITE WHEN HE CHECKED. THIS COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. THE OMNIPOD USER GUIDE WARNS, "CHECK OFTEN TO MAKE SURE THE POD AND SOFT CANNULA ARE SECURELY ATTACHED AND IN PLACE. A LOOSE OR DISLODGED CANNULA MAY INTERRUPT INSULIN DELIVERY," "BECAUSE INSULIN PODS USE ONLY RAPID-ACTING INSULIN, USERS ARE AT INCREASED RISK FOR DEVELOPING HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) IF INSULIN DELIVERY IS INTERRUPTED," AND "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA)." IT ADVISES "IF YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE, CHECK FOR KETONES. 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) 2013 AT 10 PM, HE ATE ABOUT 27 GRAMS OF CARBOHYDRATE, TOOK A 3.35 UNIT BOLUS AND SET A TEMPORARY BASAL INSULIN RATER OF 2.8 UNITS/HOUR FOR THE NEXT 3 HOURS. NO BLOOD GLUCOSE RESULTS WERE REPORTED. THE NEXT MORNING AT 6:16 AM HIS BG WAS 363 MG/DL, WHICH HE CORRECTED WITH 4.95 UNIT BOLUS. HE TOOK AN ADDITIONAL 5.5 UNIT BOLUS AT 9:26 AM, BUT DID NOT REPORT ANY BG READING OR FOOD INTAKE AT THAT TIME. AT NOON HIS BG MEASURED 413 MG/DL; HE BOLUSED 6.2 UNITS AT THAT TIME AND ANOTHER 7.5 UNITS AT 2:02 PM (AGAIN NO BG RESULT OR FOOD INTAKE WAS REPORTED AT THAT TIME). HE STATED THAT THE CANNULA WAS NOT IN THE SKIN WHEN HE LOOKED. AT 2:47 PM, THE POD WAS DEACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218259 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31076

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR