BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3010911 · Received March 6, 2013

    Report

    Report Number
    3004464228-2013-00193
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 5, 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 RETURNED DEVICE WAS EVALUATED AND PERFORMED AS DESIGNED. NO MALFUNCTION OR OTHER PRODUCT CONDITION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA WAS FOUND. LOT QUALIFICATION RECORDS WERE REVIEWED, AND THE PRODUCT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD'S 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." IT ADVISES "IF YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE, CHECK FOR KETONES. IF KETONES ARE PRESENT, FOLLOW YOUR HEALTHCARE PROVIDER'S GUIDELINES. IF KETONES ARE NOT PRESENT, TAKE A CORRECTION BOLUS AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER. CHECK BLOOD GLUCOSE AGAIN AFTER 2 HRS. IF BG LEVELS HAVE NOT DECREASED THEN TAKE A SECOND BOLUS BY INJECTION, USING A STERILE SYRINGE. IF YOU FEEL NAUSEATED AT ANY POINT, CHECK FOR KETONES AND CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY. IF BLOOD GLUCOSE REMAINS HIGH AFTER ANOTHER 2 HRS (A TOTAL OF 4 HRS), REPLACE THE POD."

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT HER DAUGHTER WENT TO THE HOSP BECAUSE HER BLOOD GLUCOSE WAS HIGH. SHE REPORTED THAT THEY WENT TO THE HOSP ON (B)(6) 2013, WHERE THE POD WAS REMOVED AND SHE WAS GIVEN INSULIN INJECTIONS AS WELL AS A MEDICATION FOR NAUSEA. WHEN THE POD WAS REMOVED, THE CANNULA WAS BENT AND COVERED IN BLOOD. THE MOTHER LATER SAID THAT SHE WAS CONFUSED ON THE DATES OF THE HOSPITALIZATION AND SAID THAT IT HAPPENED BETWEEN (B)(6) 2012 AND (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96620 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30847

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization