BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2953867 · Received February 1, 2013

    Report

    Report Number
    3004464228-2013-00076
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 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 WILL NOT RETURN FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PATIENT'S DIABETIC KETOACIDOSIS. NO PRODUCT LOT NUMBER WAS REPORTED, THEREFORE NO QUALIFICATION RECORDS COULD BE REVIEWED. 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." IT 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. CHECK BLOOD GLUCOSE AGAIN AFTER 2 HOURS. IF BLOOD GLUCOSE LEVEL HAS NOT DECLINED, IMMEDIATELY CALL YOUR HEALTHCARE PROVIDER FOR GUIDANCE," AND "THE EASIEST AND MOST RELIABLE WAY TO AVOID DKA IS BY CHECKING YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY. ROUTINE CHECKS ALLOW YOU TO IDENTIFY AND TREAT HIGH BLOOD GLUCOSE BEFORE DKA DEVELOPS."

    Description of Event or Problem · 1

    THE MOTHER OF THE PATIENT REPORTED THAT THE POD WAS ACTIVATED ON (B)(6) 2013 AT 11:00 PM. AT 1:59 AM ON 1/2 HER DAUGHTER'S BLOOD GLUCOSE MEASURED 212 MG/DL. AT 4:00 AM HER DAUGHTER WAS VOMITING. HER BLOOD GLUCOSE MEASURED 196 MG/DL AT 11:00 AM AND 340 MG/DL AT 5:17 PM. SHE WAS ADMITTED TO THE HOSPITAL AT ABOUT 5:00 PM DUE TO DIABETIC KETOACIDOSIS. ALTHOUGH HER BG WAS NOT MUCH ABOVE 300 MG/DL, SHE WAS VERY SICK AND WAS POSITIVE FOR KETONES. SHE WAS TREATED WITH AN INSULIN DRIP AND FLUIDS. BY THE TIME OF HER MOTHER'S CALL, THE PATIENT'S BG WAS NORMAL. THE CALLER NO LONGER HAD THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43618 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization