BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 10017072 · Received May 1, 2020

    Report

    Report Number
    3004464228-2020-06198
    Event Type
    Malfunction
    Date Received
    May 1, 2020
    Date of Event
    April 16, 2020
    Report Date
    April 16, 2020
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K192659
    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. THE PATIENT REPORTED THE CANNULA WAS NOT INSERTED CORRECTLY INTO 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: UST400, 17845-5A-AW REV B 09/17. CHANGING YOUR POD:   CHAPTER 3 / PAGE 34;  WARNINGS:   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.  IF YOU OBSERVE BLOOD IN THE CANNULA, CHECK YOUR BLOOD GLUCOSE FREQUENTLY TO ENSURE THAT INSULIN DELIVERY HAS NOT BEEN AFFECTED. IF YOU EXPERIENCE UNEXPECTEDLY ELEVATED BLOOD GLUCOSE LEVELS, CHANGE YOUR POD.  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.

    Additional Manufacturer Narrative · 1

    THE POD WAS RECEIVED WITH THE CANNULA DEPLOYED. NO ISSUES WERE FOUND IN THE NEEDLE MECHANISM THAT WOULD RESULT IN A FAILURE FOR THE CANNULA TO INSERT INTO THE POD INFUSION SITE. ALTHOUGH NO ISSUES WERE FOUND IN THE NEEDLE MECHANISM, THE ACTUAL CAUSE OF THE REPORTED EVENT OF CANNULA UNSURE PROPERLY INSERTED COULD NOT BE DETERMINED. THE EXPOSED PORTION OF SOFT CANNULA WAS OBSERVED TO BE KINKED. IT COULD NOT DETERMINED WHEN THIS DAMAGE OCCURRED. THE POD DOWNLOAD DATA DID NOT INDICATE ANY PULSE WIDTH INCREASES OR SIGNS OF STRUGGLE IN DELIVERING INSULIN DURING OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 260 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE (ARM). AS TREATMENT, A MANUAL INJECTION WAS ADMINISTERED., "FLUSHED" WITH WATER, EXERCISED AND A NEW POD WAS APPLIED. THE PATIENT'S BLOOD GLUCOSE AND INSULIN HISTORY ARE AS FOLLOWS: TIME: 4:00PM, BG(MG/DL): 118; BOLUS(U); "BEFORE BED", 260, 4; 1:30, 130; 237, 241 (CHANGED POD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481986 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L45195 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR