BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2935140 · Received January 24, 2013

    Report

    Report Number
    3004464228-2013-00066
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 28, 2012
    Manufacturer
    INSULET CORP
    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 REPORTED 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). IF YOUR 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 "IF YOUR HAVE FILLED THE POD WITH MORE THAN 85 UNITS AND STILL DO NOT HEAR THE 2 BEEPS, CALL CUSTOMER CARE," AND "TO AVOID HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) CHECK YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY (WHEN YOUR WAKE UP, BEFORE EACH MEAL, AND BEFORE GOING TO BED). IN ADDITION, ALWAYS CHECK IF YOU FEEL NAUSEATED OR SICK."

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT HER DAUGHTER WAS VOMITING AND HER BLOOD GLUCOSE MEASURED "HIGH" (>500 MG/DL). SHE WAS HOSPITALIZED OVERNIGHT, UNTIL HER BG WENT DOWN. SHE WAS TREATED WITH AN INJECTION OF NOVALOG. THE MOTHER STATED THAT THE POD DID NOT "DOUBLE BEEP" DURING ACTIVATION AND THAT THEY CHANGED IT "AFTER THEY REALIZED THAT THE POD WAS NOT WORKING." NO SPECIFIC TIMES FOR ANY OF THESE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34757 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORP 11200 L30920

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization