BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3001740 · Received March 7, 2013

    Report

    Report Number
    3004464228-2013-00194
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 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 EVAL. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PT'S HYPERGLYCEMIA AND HOSPITALIZATION. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. 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," AND ADVISES "IF YOUR BLOOD GLUCOSE IS 250 MG/DL OR ABOVE, CHECK FOR KETONES. IF KETONES ARE NOT PRESENT, TAKE A CORRECTION BOLUS AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER. CHECK BLOOD GLUCOSE AGAIN AFTER 2 HOURS. IF BLOOD GLUCOSE LEVELS HAVE NOT DECREASED, 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 HOURS (A TOTAL OF 4 HOURS), REPLACE THE POD. USE A NEW VIAL OF INSULIN TO FILL THE NEW POD."

    Description of Event or Problem · 1

    THE PT REPORTED THAT HER BLOOD GLUCOSE WAS 165 MG/DL AND THEN STARTED TO RISE, MEASURING 290 MG/DL, 280 MG/DL, 425 MG/DL AND 530 MG/DL. AFTER THAT IT BEGAN TO DECREASE AGAIN, READING 380 MG/DL, 325 MG/DL AND FINALLY 260 MG/DL (NO TIMES OR INSULIN DOSAGES WERE REPORTED FOR ANY OF THESE TEST RESULTS). SHE WAS FEELING SICK AND WENT TO THE HOSP WHERE SHE STAYED FOR ABOUT SEVEN HOURS. SHE WAS TREATED WITH AN INSULIN DRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97452 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30937

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization