BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3072894 · Received April 12, 2013

    Report

    Report Number
    3004464228-2013-00342
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 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 DISCARDED AND WILL NOT BE RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD USER'S GUIDE WARNS "IF YOU OBSERVE BLOOD IN THE CANNULA, CHECK YOUR BLOOD GLUCOSE MORE FREQUENTLY TO ENSURE INSULIN DELIVERY HAS NOT BEEN EFFECTED. IF YOU EXPERIENCE UNEXPECTED ELEVATED BLOOD GLUCOSE LEVELS, CHANGE YOUR POD." "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 "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 AT 6:11 PM HER BLOOD GLUCOSE WAS 358 MG/DL AND SHE WAS HAVING ABOUT 55 GRAMS OF CARBOHYDRATE, SO SHE TOOK AN 8 UNIT INSULIN BOLUS. AT 10:00 PM HER BG WAS 397 MG/DL, SO SHE CHANGED THE POD AND CORRECTED WITH A 9 UNIT BOLUS WITH THE NEW DEVICE. SHE STATED THAT THE CANNULA WAS BENT AND HAD BLOOD IN IT. THE NEXT MORNING HER BG WAS 171 MG/DL. SHE ALSO REPORTED THAT SHE IS ON SPRING BREAK AND HAS BEEN PHYSICALLY ACTIVE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158125 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31001

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR