BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2974125 · Received February 13, 2013

    Report

    Report Number
    3004464228-2013-00119
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 15, 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 DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY MALFUNCTION OR OTHER PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE PT'S DIABETIC KETOACIDOSIS AND HOSPITALIZATION. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO QUALIFICATION RECORDS COULD BE REVIEWED. THE OMNIPOD USER GUIDE WARNS "HIGH" BLOOD GLUCOSE READINGS CAN INDICATE A POTENTIALLY SERIOUS CONDITION REQUIRING IMMEDIATE MEDICAL ATTENTION. IF LEFT UNTREATED, THIS SITUATION CAN QUICKLY LEAD TO DIABETIC KETOACIDOSIS (DKA), SHOCK, COMA, OR DEATH," AND "IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS 'HIGH CHECK FOR KETONES!' THIS INDICATES SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE). IF YOU GET A 'HIGH CHECK FOR KETONES!' READING AND FEEL SYMPTOMS SUCH AS FATIGUE, THIRST, EXCESS URINATION, OR BLURRY VISION, FOLLOW YOUR HEALTHCARE PROVIDER'S RECOMMENDATION TO TREAT HYPERGLYCEMIA." IT ADVISES "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," 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 YOUR TO IDENTIFY AND TREAT HIGH BLOOD GLUCOSE BEFORE DKA DEVELOPS."

    Description of Event or Problem · 1

    THE PT'S FATHER REPORTED THE FOLLOWING BLOOD GLUCOSE AND TREATMENT HISTORY FOR (B)(6) 2013. THE PT WAS HOSPITALIZED FOR DKA. AT 2/29 PM HER BG MEASURED 465 MG/DL AND ANOTHER 5 UNITS WAS BOLUSED. AT 3:45 THE POD WAS DEACTIVATED AND DISCARDED. THE FATHER REPORTED THAT HIS DAUGHTER WAS ALSO BEING REPORTED FOR A STOMACH VIRUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64423 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization