BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 8662220 · Received June 3, 2019

    Report

    Report Number
    3004464228-2019-04785
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    April 15, 2019
    Report Date
    May 14, 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 DEVICE WAS NOT RETURNED FOR EVALUATION. THE PATIENT REPORTED THAT 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: ENT450, 17845-5C-AW REV A 10/17. CHANGING YOUR POD 3 / PAGE 34: WARNING: 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S BLOOD GLUCOSE AND INSULIN HISTORY IS AS FOLLOWS: TIME: 01:30, BG (MMOL/L((MG/DL): ¿HIGH¿ (> 27.8) (> 500), MANUAL INJECTION WITH AN INSULIN PEN (EXACT AMOUNT WAS NOT PROVIDED). TIME: 07:00, BG(MMOL/L)(MG/DL): 14.0, BOLUS (U): 252. IT WAS NOTICED THAT THE SITE WAS WET WITH INSULIN AND UPON INSPECTION IT WAS NOTICED THAT THE CANNULA HAD CAME OUT OF THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457778 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44344 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR