BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3883924 · Received June 12, 2014

    Report

    Report Number
    3004464228-2014-00819
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PATIENT'S HYPERGLYCEMIA AND HOSPITALIZATION. NO PRODUCT LOT NUMBER WAS REPORTED, THEREFORE NO QUALIFICATION RECORDS COULD BE REVIEWED. THE OMNIPOD USER GUIDE WARNS THE USER THAT TEST RESULTS GREATER THAN 13.9 MMOL/L [250 MG/DL] MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA) AND TO FOLLOW HEALTHCARE PROVIDER TREATMENT ADVICE WHEN TEST RESULTS ARE ABOVE 13.9 MMOL/L [250 MG/DL] AND ADVISES THE USER THAT TO AVOID HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) CHECK BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY (UPON WAKING, BEFORE EACH MEAL, AND BEFORE GOING TO BED).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED AT ONE POINT IN TIME FOR HIGH BLOOD GLUCOSE LEVELS. NO DATES OR TREATMENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348397 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5N

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization