BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD

    MDR report key: 8199603 · Received December 26, 2018

    Report

    Report Number
    MW5082617
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    December 19, 2018
    Report Date
    December 24, 2018
    Manufacturer
    INSULET CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    AN OMNIPOD INSULIN PUMP CONTROLLER FAILED. IT TERMINATED CONTACT WITH THE INSULIN POD AND WASTED THE CONTENTS OF INSULIN. THIS HAS HAPPENED FOUR TIMES. INSULET CORP IS THE MANUFACTURER. WE WERE ABLE TO CONTACT THEM ONLY ONCE LAST SPRING. WE WERE TOLD AT THAT TIME TO "TRY OT AGAIN" AND CALL BACK IF FAILED AGAIN. WE HAVE NOT BEEN ABLE TO GET THROUGH TO SPEAK TO A HUMAN SINCE THEN. THE "CUSTOMER SERVICE" APPEARS TO BE NON-EXISTENT. MY WIFE IS A DIABETIC. SHE NEEDS THE INSULIN. IT IS OUTRAGEOUS THAT A CORPORATION IN THE U.S. IS ALLOWED TO SELL MEDICAL DEVICES OF SUCH CRITICALLY AND NOT SUPPORT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034217 OMNIPOD PUMP, INFUSION, INSULIN FRN INSULET CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR