BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 7340591 · Received March 15, 2018

    Report

    Report Number
    3004464228-2018-01578
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 16, 2018
    Report Date
    February 19, 2018
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND PERFORMED AS DESIGNED. NO BEND OR KINK WAS OBSERVED IN THE CANNULA. NO MALFUNCTION OR OTHER PRODUCT CONDITIONS WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. MYLIFE OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE MODEL: ENT450 14518-5C-AW REV E 03/16 CHECKING YOUR BLOOD GLUCOSE 7 / PAGE 96 WARNING: TEST RESULTS GREATER THAN 13.9 MMOL/L MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). WARNING: IF YOU GET RESULTS BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE CHAPTER 9, LIVING WITH DIABETES), REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HIS BLOOD GLUCOSE REACHED BETWEEN 14.0, 17.6 AND 19 MMOL/L (252, 317 AND 342 MG/DL) AND THAT THE CANNULA WAS BENT. THE POD WAS WORN LONGER THAN 48 HOURS. HYPERGLYCEMIA TREATED BY PATIENT WITH A CORRECTION BOLUS OF 5.0 UNITS OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186070 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810 L42800

    Patients

    Seq Age Sex Outcome Treatment
    1