BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 7947280 · Received October 9, 2018

    Report

    Report Number
    3004464228-2018-06617
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    September 6, 2018
    Report Date
    September 10, 2018
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED BENT CANNULA OR TO DETERMINE WHETHER IT 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: CAT45E/CAT45F, 15546-AW REV D 06/2016, CHECKING YOUR BLOOD GLUCOSE 7 / PAGE 98. 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 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, CARBOHYDRATE INTAKE AND INSULIN HISTORY IS AS FOLLOWS: TIME BG (MMOL/L) (MG/DL) CHO (G) BOLUS (U) TIME: 11:00 AM, BG (MMOL/L) (MG/DL): 6.8, CHO (G): ATE BREAKFAST 123, BOLUS (U): BOLUS (EXACT AMOUNT WAS NOT PROVIDED); THE PATIENT DID A CORRECTIONAL BOLUS (EXACT AMOUNT WAS NOT PROVIDED) BEFORE GOING OUT FOR A RUN. 7:00 PM, 20, 360. THE POD WAS DEACTIVATED AND IT WAS NOTICED THE CANNULA WAS BENT. HYPERGLYCEMIA TREATED BY PATIENT ACTIVATING NEW POD. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787932 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 15880 L43948

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR