BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3070976 · Received March 29, 2013

    Report

    Report Number
    3004464228-2013-00284
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 3, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE KINKED CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT QUALIFICATION RECORDS WERE REVIEWED, AS A PRODUCT LOT NUMBER WAS NOT PROVIDED. 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, "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 ALSO ADVISES, "TO AVOID HYPERGLYCEMIA (HIGH BLOOD GLUCOSE), CHECK YOUR BLOOD GLUCOSE AT LEAST 4-6 TIMES A DAY (WHEN YOU WAKE UP, BEFORE EACH MEAL, AND BEFORE GOING TO BED)."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE ACTIVATED THE POD ON (B)(6) 2013. AT 3:15PM ON (B)(6), HIS BLOOD GLUCOSE RESULT WAS "HIGH" (>500 MG/DL), AND HE TESTED POSITIVE FOR KETONES. HE THEN DEACTIVATED THE POD. HE STATED THAT THE CANNULA WAS KINKED IN A 45 DEGREE ANGLE WHEN HE REMOVED THE POD. HE WAS NOT ABLE TO PROVIDE A LOT NUMBER, AS HE HAD DISPOSED OF THE POD. HE SAID THAT HE WAS FEELING LETHARGIC AND THIRSTY, AND HAD ACTIVATED A NEW POD AND GAVE HIMSELF AN 8 UNIT BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131137 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR