BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 6003157 · Received October 6, 2016

    Report

    Report Number
    3004464228-2016-03151
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    August 7, 2016
    Report Date
    September 13, 2016
    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 DEFECT OR DEFICIENCY THAT WOULD RESULT IN THE CANNULA FAILING TO INSERT CORRECTLY OR THE PUMP FAILING TO DELIVER INSULIN WAS FOUND. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. 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. VERIFY THAT THERE IS NO WETNESS OR SCENT OF INSULIN, WHICH MAY INDICATE THE CANNULA HAS DISLODGED," "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). 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."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE REACHED 300MG/DL WHILE WEARING THE POD FOR 1 DAY (BETWEEN 4 AND 24 HOURS). HE WAS NOT SURE IF THE CANNULA WAS IN/KINKED. THE PRODUCT WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658021 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810 L42320

    Patients

    Seq Age Sex Outcome Treatment
    1