BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 7960796 · Received October 12, 2018

    Report

    Report Number
    3004464228-2018-06817
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    September 1, 2018
    Report Date
    September 14, 2018
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K122953
    Product Problem
    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 CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED BECAUSE NO PRODUCT LOT NUMBER WAS REPORTED. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE MODEL: ENT450 17845-5C-AW REV A 10/17 CHECKING YOUR BLOOD GLUCOSE 4 / PAGE 36 WARNINGS: TEST RESULTS GREATER THAN 13.9 MMOL/L MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). WARNINGS: 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.

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS EVALUATED AND PERFORMED AS DESIGNED. NO BEND OR KINK WAS OBSERVED IN THE CANNULA. NO MALFUNCTION OR OTHER PRODUCT CONDITIONS WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA.

    Additional Manufacturer Narrative · 1

    LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. CORRECTION: LOT NUMBER CHANGED FROM UNAVAILABLE TO L43509. EXPIRATION DATE CHANGED FROM UNAVAILABLE TO 6/1/2019. MODEL NO CHANGED FROM 19191 TO 14810. PMA/510(K) # CHANGED FROM K162296 TO K122953. DEVICE MFG DATE CHANGED FROM UNAVAILABLE TO 12/1/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE REACHED 20 MMOL/L (360 MG/DL) AND THAT THE CANNULA WAS BENT. HYPERGLYCEMIA TREATED BY PATIENT WITH A MANUAL INJECTION OF INSULIN (EXACT AMOUNT WAS NOT PROVIDED). THE POD WAS WORN BETWEEN 24 AND 36 HOURS ON THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803004 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L43509 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR