BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD

    MDR report key: 3427244 · Received October 21, 2013

    Report

    Report Number
    MW5032363
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Date of Event
    September 15, 2013
    Report Date
    October 20, 2013
    Manufacturer
    INSULET CORP.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM AN INSULET OMNIPOD USER. I SWITCHED TO THE NEW (UST400-BASE) SYSTEM ON (B)(6) 2013. AS OF THIS WRITING, I HAVE EXPERIENCED A 17% FAILURE RATE (3/17) N OF THE "POD" COMPONENT IN THE OMINPOD SYSTEM. FAILURE IN THIS CASE MEANS THE POD SHUT DOWN PRIOR TO ITS INTENDED 72 HOUR MISSION PROFILE. THE DATES OF FAILURE, ERROR CODES AND FAILURE DESCRIPTION ARE SUMMARIZED BELOW. I HAVE REPORTED ALL OF THESE TO THE MANUFACTURER. THE MANUFACTURER WILL NOT COMMIT TO PROVIDING DETAILED FAILURE INFORMATION, NOR WILL THEY CONFIRM WHAT MEASURES THEY WILL TAKE TO PREVENT FURTHER FAILURES. I AM REPORTING THESE EVENTS TO BE PROACTIVE IN THE HOPES THAT THE MANUFACTURER ADDRESSES THEIR APPARENT PROBLEMS AS SOON AS POSSIBLE. [DATE OF FAILURE: (B)(6) 2013, ERROR CODE: 1900500-00251-092, DESCRIPTION: PRIMING ERROR, LOT: L40464-0014046; 09/20/2013, 19-04046-07151-106, POD ERROR, L40464-0014003; (B)(6) 2013, 19-04046-06451-105, POD ERROR, L40564-0001644.]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538746 OMNIPOD OMNIPOD LZG INSULET CORP. UST400 L40464-0014046
    538747 OMNIPOD OMNIPOD LZG INSULET CORP. UST400 L40464-0014003
    538748 OMNIPOD OMNIPOD LZG INSULET CORP. UST400 L40564-0001644

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR