BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 8922040 · Received August 22, 2019

    Report

    Report Number
    3004464228-2019-07944
    Event Type
    Injury
    Date Received
    August 22, 2019
    Date of Event
    August 7, 2019
    Report Date
    August 10, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HYPOGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: UST400. 17845-5A-AW REV B 09/17. CHECKING YOUR BLOOD GLUCOSE. CHAPTER 4 / PAGE 36. WARNINGS: TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS BELOW 70 MG/DL OR ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE "LIVING WITH DIABETES" ON PAGE 115), 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 ADVICE OF YOUR HEALTHCARE PROVIDER. LIVING WITH DIABETES. CHAPTER 11 / PAGE 119. HYPOGLYCEMIA CAN OCCUR EVEN WHEN A POD IS WORKING PROPERLY. NEVER IGNORE THE SIGNS OF LOW BLOOD GLUCOSE, NO MATTER HOW MILD. IF LEFT UNTREATED, SEVERE HYPOGLYCEMIA CAN CAUSE SEIZURES OR LEAD TO UNCONSCIOUSNESS. IF YOU SUSPECT THAT YOUR BLOOD GLUCOSE LEVEL IS LOW, CHECK YOUR BLOOD GLUCOSE LEVEL TO CONFIRM.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT AROUND 6-7 PM HIS BLOOD GLUCOSE (BG) REACHED 311 MG/DL. HE DID A CORRECTION BOLUS OF ABOUT 14 UNITS (IN ANTICIPATION OF A MEAL AND ICE CREAM, AS WELL AS HIGH BG LEVELS) AROUND 8:52 PM. PATIENT STATED HE BELIEVES HE JUST OVER BOLUSED, AS HE HAS BEEN WORKING A LOT AND HAS BEEN REALLY TIRED, MAY HAVE NOT BEEN PAYING TOO MUCH ATTENTION. HE USES THE BOLUS CALCULATOR AND USUALLY ADDS A FEW MORE UNITS. THE NEXT MORNING AT AROUND 6 AM HIS BG WAS 19 MG/DL OR 20 MG/DL. AN AMBULANCE WAS CALLED, AS HIS BG WAS EXTREMELY LOW. PATIENT STATED HE WAS REALLY OUT OF IT WHEN THEY ARRIVED AND DOES NOT KNOW HOW MUCH GLUCAGON (VIA SHOT) WAS GIVEN TO HIM. THE PARAMEDICS WERE THERE FOR ABOUT 45 ¿ 60 MINUTES AND HIS GIRLFRIEND GAVE HIM A PEANUT BUTTER AND JELLY SANDWICH. THE POD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715446 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR