BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 10006122 · Received April 28, 2020

    Report

    Report Number
    3004464228-2020-06037
    Event Type
    Malfunction
    Date Received
    April 28, 2020
    Date of Event
    March 11, 2020
    Report Date
    March 11, 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 RETURNED DEVICE WAS EVALUATED AND THE EXPOSED SOFT CANNULA WAS FOUND TO BE BENT FOR THE RECEIVED POD. DESPITE THIS DAMAGE, THE FLUID WAS FOUND TO PASS FREELY THROUGH THE COMPLETE FLUID PATH DURING INVESTIGATION. IT COULD NOT BE DETERMINED WHEN THIS DAMAGE ON SOFT CANNULA OCCURRED. THE DOWNLOAD DATA DID NOT CONTAIN ANY TIMEOUTS OR PULSE WIDTH INCREASES THAT WOULD INDICATE A FAILURE TO DELIVER INSULIN. CRACKS WERE OBSERVED ON THE OUTER HOUSING. IT COULD NOT BE DETERMINED WHEN THESE CRACKS HAD OCCURRED. INSPECTION OF THE DEVICE ALONG WITH THE DATA SUGGEST THAT THE CRACKS HAD NO EFFECT ON THE DEVICE'S FUNCTIONALITY. 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.  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 WHILE A PATIENT WAS WEARING A POD BETWEEN 4 AND 24 HOURS THEIR BLOOD GLUCOSE LEVEL ROSE TO 358 MG/DL. AS TREATMENT, THE PATIENT WAS GIVEN A CORRECTION OF 1.5 UNITS OF INSULIN AND A BOLUS WAS PERFORMED. THE PATIENT'S BLOOD GLUCOSE HISTORY ARE AS FOLLOWS: TIME: 1:45 PM, BG(MG/DL): 358; 4:00 PM, 240; 188; 330.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470996 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L70129 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR