BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 9382566 · Received November 27, 2019

    Report

    Report Number
    3004464228-2019-12291
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    September 28, 2019
    Report Date
    September 30, 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 RETURNED DEVICE WAS EVALUATED AND THE INVESTIGATION FOUND A HOLE IN THE EXPOSED PORTION OF THE SOFT CANNULA. WHEN THE DISTAL TIP WAS MANUALLY OCCLUDED, FLUID DIVERTED THROUGH THE HOLE. ALTHOUGH THE CANNULA WAS DAMAGED, THE TIMING AND CAUSE OF THE DAMAGE ARE UNKNOWN. THOUGH THE ROOT CAUSE WAS NOT SPECIFICALLY DETERMINED, DURING MANUFACTURING THERE IS A MINIMAL PROBABILITY OF A PROCESS PROBLEM OCCURRING. THIS IS MITIGATED BY EXTENSIVE IN-LINE AND FINAL PRODUCT QUALITY TESTING. ALL POD COMPLAINT RATES ARE MONITORED, TRENDED AND ESCALATED BASED ON INSULET CORPORATION PROCEDURAL REQUIREMENTS. NO FURTHER ACTION OR INVESTIGATION IS WARRANTED AT THIS TIME. 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

    THE PATIENT REPORTS WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE LEG HER BLOOD GLUCOSE (BG) LEVEL WAS READING AT 269 MG/L. AS TREATMENT, THE PATIENT WENT FOR A WALK, APPLIED A NEW POD AND ALSO LOWERED HER USUAL CARBOHYDRATE INTAKE. THE PATIENT'S BLOOD GLUCOSE HISTORY ARE AS FOLLOWS: TIME: 28 SEPTEMBER BG(MG/DL): 89; 121, 167; 29 SEPTEMBER 8:30 PM, 244; 9:00 PM, 268; 9:50 PM, 269; 30 SEPTEMBER 7.38, 127.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179378 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L44533 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR