BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3173008 · Received May 30, 2013

    Report

    Report Number
    3004464228-2013-00530
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 5, 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 EVAL. WE ARE UNABLE TO CONFIRM THE KINKED CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS, "TEST RESULTS GREATER THAN 13.9 MMOL/L [250 MG/DL] MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS ABOVE 13.9 MMOL/L [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 13.9 MMOL/L [250 MG/DL], FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER." IT ADVISES, "IF YOUR BLOOD GLUCOSE IS 13.9 MMOL/L [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 CUSTOMER'S MOTHER REPORTED THAT HER DAUGHTER HAD HYPERGLYCEMIA WHILE WEARING A POD. SHE PROVIDED THE FOLLOWING BLOOD GLUCOSE HISTORY: SEE SCANNED TABLE. SHE REMOVED THE POD BECAUSE FOR THE HIGH BLOOD GLUCOSE RESULTS. SHE SAID THAT THE CANNULA WAS KINKED, AND THE ADHESIVE WAS PEELED BACK AROUND THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239175 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14820 L31055

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR