BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 9328626 · Received November 15, 2019

    Report

    Report Number
    3004464228-2019-11971
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Date of Event
    October 31, 2019
    Report Date
    October 31, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    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 FULLY DEPLOYED. INSPECTION OF THE CANNULA ASSEMBLY FOUND NO PROBLEMS WITH FLUID PASSING FREELY THROUGH THE COMPLETE FLUID PATH, THOUGH THE EXPOSED PORTION OF THE SOFT CANNULA WAS KINKED. IT COULD NOT BE DETERMINED WHEN THIS DAMAGE OCCURRED. THE DATA SHOWED NO TIMEOUTS, DRIVE STALLS, OR PULSE WIDTH INCREASES THAT WOULD INDICATE THE POD STRUGGLING TO DELIVER INSULIN WHILE WORN.SEQUENCE NUMBER CHANGED FROM 000691 TO 0000691.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED 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. 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 PATIENT'S BLOOD GLUCOSE (BG) REACHED BETWEEN 358 TO 403 MG/DL WHILE WEARING THE POD FOR UNKNOWN HOURS. THE POD¿S CANNULA WAS FOUND BENT, WHILE WEARING IT ON THE ABDOMEN. FOR TREATMENT, THE PATIENT GAVE A MANUAL INJECTION OF INSULIN AFTER FAILED BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124084 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L42222 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR