BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 8459514 · Received March 28, 2019

    Report

    Report Number
    3004464228-2019-02448
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    March 3, 2019
    Report Date
    March 3, 2019
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120002
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SOFT CANNULA WAS IN THE DEPLOYED STATE WHEN THE DEVICE WAS RECEIVED. THE DEVICE SHOWED NO EVIDENCE OF DAMAGE OR MANUFACTURING DEFICIENCIES THAT WOULD CAUSE THE NEEDLE TO DEPLOY EARLY. THE DATA SHOWED THAT THE FIRST PRIMING SEQUENCE ENDED AT 46 PULSES AND DEACTIVATION OCCURRED AT 56 PULSES. ALTHOUGH THE NEEDLE MECHANISM WAS RESET AND FIRED PROPERLY DURING THE INVESTIGATION, THE REPORTED EVENT COULD NOT BE DETERMINED. CORRECTION (DEVICE AVAILABLE FOR EVAL: YES, DATE RETURNED TO MFG: 3/252019) THE DEVICE HAD BEEN RECEIVED AT THE TIME OF INITIAL REPORT. CORRECTION (DEVICE RETURNED TO MANUFACTURER? YES) THE DEVICE HAD BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE. 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. CHANGING YOUR POD. CHAPTER 3 / PAGES 33. WARNING: CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT. 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 THE PATIENT¿S BLOOD GLUCOSE (BG) REACHED 344 MG/DL WHILE NOT WEARING THE POD. WHEN PATIENT PRESSED START, SHE REALIZED THE NEEDLE HAD NOT DEPLOYED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254086 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L44382 20385081120002

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR