BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 8649245 · Received May 29, 2019

    Report

    Report Number
    3004464228-2019-04612
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    May 8, 2019
    Report Date
    May 9, 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 · 1

    THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY DEPLOYED. INSPECTION OF THE FLUID PATH FOUND THE EXPOSED PORTION OF THE SOFT CANNULA TO BE BENT. ALTHOUGH THIS DAMAGE WAS FOUND, IT CANNOT BE DETERMINED WHEN OR HOW THIS DAMAGE OCCURRED. 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. 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: ENT450; 17845-5C-AW REV A 10/17. CHECKING YOUR BLOOD GLUCOSE 4 / PAGE 36: WARNING: TEST RESULTS GREATER THAN 13.9 MMOL/L MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). WARNING: IF YOU GET RESULTS BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE "LIVING WITH DIABETES" ON PAGE 117), REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 3.9 MMOL/L OR ABOVE 13.9 MMOL/L, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 420 MG/DL, WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE ABDOMEN. THE PATIENT REPORTED THE INFUSION SITE BEING BLOODY. THE POD WAS REMOVED AND THE CANNULA WAS NOTED TO BE BENT. A MANUAL INSULIN INJECTION USING A PEN WAS ADMINISTERED TO TREAT THE HYPERGLYCEMIA AND A NEW POD WAS APPLIED. THE PATIENT'S BLOOD GLUCOSE HISTORY IS AS FOLLOWS: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445629 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44282 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR