BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 8649165 · Received May 29, 2019

    Report

    Report Number
    3004464228-2019-04601
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    March 31, 2019
    Report Date
    May 8, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K162296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY DEPLOYED. INSPECTION OF THE NEEDLE MECHANISM ASSEMBLY FOUND NO EVIDENCE THAT WOULD RESULT IN THE CANNULA DISLODGING; A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED, NO OTHER DEFECTS OR DEFICIENCIES WERE FOUND THAT WOULD RESULT IN A FAILURE OF THE DEVICE TO DELIVER INSULIN.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: UST400; 17845-5A-AW REV B 09/17. CHANGING YOUR POD: CHAPTER 3 / PAGE 34. WARNINGS: CHECK OFTEN TO MAKE SURE THE POD AND SOFT CANNULA ARE SECURELY ATTACHED AND IN PLACE. A LOOSE OR DISLODGED CANNULA MAY INTERRUPT INSULIN DELIVERY. VERIFY THAT THERE IS NO WETNESS OR SCENT OF INSULIN, WHICH MAY INDICATE THAT THE CANNULA HAS DISLODGED. IF YOU OBSERVE BLOOD IN THE CANNULA, CHECK YOUR BLOOD GLUCOSE FREQUENTLY TO ENSURE THAT INSULIN DELIVERY HAS NOT BEEN AFFECTED. IF YOU EXPERIENCE UNEXPECTEDLY ELEVATED BLOOD GLUCOSE LEVELS, CHANGE YOUR POD. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 320 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS. THE CUSTOMER CALLING IN TO REPORT A POD THAT CAME LOOSE, CUSTOMER BELIEVES THAT THE POD CAME LOOSE AND CANNULA CAME OUT COMPLETELY (LEG). AS TREATMENT, A MANUAL INJECTION WAS DELIVERED AND A NEW POD WAS APPLIED AFTER THE EVENT. THE PATIENT'S BLOOD GLUCOSE AND INSULIN HISTORY ARE AS FOLLOWS: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443711 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44189 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR