BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 5948760 · Received September 14, 2016

    Report

    Report Number
    3004464228-2016-02806
    Event Type
    Injury
    Date Received
    September 14, 2016
    Date of Event
    August 17, 2016
    Report Date
    August 18, 2016
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RECEIVED FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY MALFUNCTION/DETERMINE IF DEVICE BEHAVIOR COULD HAVE CONTRIBUTED TO THE REPORTED HIGH BLOOD GLUCOSE LEVEL, DEHYDRATION, AND SUBSEQUENT ER VISIT. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. THE OMNIPOD USER GUIDE WARNS, "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 HER BG LEVEL WAS "HIGH" (>500 MG/DL) AND SHE DID NOT FEEL THE POD WAS DELIVERING INSULIN ACCURATELY. SHE WAS ADMITTED TO THE HOSPITAL FOR THE HIGH BGS AND DEHYDRATION. SHE WAS TREATED BY MANUAL INSULIN INJECTION AND IV FLUID. AT: 1012 AM = 346, 0652 PM = HI, 0754 PM = HI, 1014 PM = 423, 1157 PM - 357.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601503 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R