BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3001744 · Received March 7, 2013

    Report

    Report Number
    3004464228-2013-00203
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 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 WHICH WAS RETURNED, WHILE MATCHING THE LOT AN IDENTIFICATION NUMBERS REPORTED BY THE PT, WAS DEACTIVATED IMMEDIATELY AFTER NEEDLE INSERTION AN COULD NOT HAVE CONTRIBUTED TO REPORTED HIGH OR SUBSEQUENT LOW BLOOD GLUCOSE. THE INCORRECT DEVICE WAS RETURNED FOR THE REPORTED EVENT. WE ARE THEREFORE UNABLE TO DETERMINE IF THE REPORTED NEEDLE RETRACTION ISSUE CONTRIBUTED TO THE EVENT. NO QUALIFICATION RECORD REVIEW WAS PERFORMED. THE OMNIPOD USER GUIDE WARNS "TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA)," "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA)," AND "IF YOU GET RESULTS BELOW 70 MG/DL OR ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA, REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL OR ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVISE OF YOUR HEALTHCARE PROVIDER." IT ADVISES "ALWAYS CHECK YOUR BLOOD GLUCOSE LEVELS FREQUENTLY WHILE TREATING HYPERGLYCEMIA. YOU DON'T WANT TO OVER-TREAT THE CONDITION AND CAUSE YOUR BG LEVEL TO DROP TOO FAR," AND "YOU CAN AVOID MOST RISKS RELATED TO USING THE OMNIPOD SYS BY PRACTICING PROPER TECHNIQUES AND BY ACTING PROMPTLY AT THE FIRST SIGN OF TROUBLE. YOU CAN AVOID POTENTIAL PROBLEMS BY KNOWING THE SIGNS OF HYPOGLYCEMIA (LOW BLOOD GLUCOSE), HYPERGLYCEMIA (HIGH BLOOD GLUCOSE), AND DIABETIC KETOACIDOSIS (DKA). THE EASIEST AND MOST RELIABLE WAY TO AVOID THESE CONDITIONS IS TO CHECK YOUR BLOOD GLUCOSE OFTEN."

    Description of Event or Problem · 1

    THE PT REPORTED THAT AT 6:00 AM HER BLOOD GLUCOSE WAS 70 MG/DL, SO SHE ATE BREAKFAST WITH NO MEAL BOLUS. AT 8:30 AM HER BG WAS UP TO 127 MG/DL. SHE REPORTED THAT SHE HAD HALF SANDWICH AND AGAIN DID NOT BOLUS FOR THE MEAL. AT 11:42 AM, WITH BG MEASURING 375 MG/DL, SHE DID NOT FEEL WELL. SHE ATE SOME KIWI AND ENTERED 26 GRAMS OF CARBOHYDRATE TO CALCULATE AND ADMINISTERED A BOLUS OF 3.40 UNITS. SHE STILL DID NOT FEEL WELL, STARTED SWEATING AND HAD TO GO TO THE EMERGENCY ROOM, DUE TO HER BG GOING DOWN TO 34 MG/DL. WHEN SHE ARRIVED, HER BG WAS 30 MG/DL. AT 1:34 PM HER BG WAS 165 MG/DL AND SHE TOOK 3.40 UNIT BOLUS. AT 1:50 PM HER BG WAS 165 MG/DL AND AT 2.13 PM BASAL INSULIN WAS SUSPENDED. IT WAS RESUMED AT 4:12 PM AND SHE WAS RELEASED AT 6:30 PM, AFTER SHE WAS STABILIZED. WHEN SHE REMOVED THE PD, SHE STATED THAT THE ADHESIVE WAS WET AND SHE BLED A LITTLE. SHE OBSERVED THAT THE NEEDLE WAS STILL STICKING OUT. SHE ALSO STATED THAT SHE "DID NOT KEEP TRACK OF THE POD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98317 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30976

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other