BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3021056 · Received March 12, 2013

    Report

    Report Number
    3004464228-2013-00220
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    December 20, 2012
    Report Date
    February 12, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT 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. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER GUIDE WARNS "IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS 'HIGH CHECK FOR KETONES' THIS INDICATES SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE)," AND ADVISES "ONCE YOU HAVE BEGUN TREATMENT FOR HIGH BLOOD GLUCOSE, CHECK FOR KETONES. CHECK FOR KETONES ANY TIME YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE. IF KETONES ARE NEGATIVE OR TRACE, CONTINUE TREATING FOR HIGH BLOOD GLUCOSE. IF KETONES ARE PRESENT, AND YOU ARE FEELING NAUSEATED OR ILL, IMMEDIATELY CALL YOUR HEALTHCARE PROVIDER FOR GUIDANCE. IF KETONES ARE POSITIVE, BUT YOU ARE NOT FEELING NAUSEATED OR ILL, REPLACE THE POD, USING A NEW VIAL OF INSULIN. CHECK BLOOD GLUCOSE AGAIN AFTER 2 HOURS. IF BLOOD GLUCOSE LEVEL HAS NOT DECLINED, IMMEDIATELY CALL YOUR HEALTHCARE PROVIDER FOR GUIDANCE."

    Description of Event or Problem · 1

    THE PATIENT'S SISTER REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR TWO DAY PT WAS IN HCP FOR 2 DAYS ON (B)(6) 2012 FOR HIGH BGS PTS BGS WAS OVER 500. IN A FOLLOW UP CALL THE PATIENT'S MOTHER REPORTED THAT HER DAUGHTER WAS ADMITTED TO THE INTENSIVE CARE UNIT WITH BLOOD GLUCOSE OVER 600 MG/DL AND KETONES. SHE SPOKE WITH AN INSULET CLINICAL SERVICES MANAGER WHILE HOSPITALIZED. SOME CHANGES WERE MADE TO THE PATIENT'S PDM SETTINGS AND SHE WAS GIVEN SOMETHING TO HELP THE PODS ADHERE TO HER SKIN BETTER. THE MOTHER STATED HER DAUGHTER'S BEEN DOING BETTER SINCE HER RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104479 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L6182

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization