BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 2003519 · Received February 20, 2011

    Report

    Report Number
    MW5019525
    Event Type
    Injury
    Date Received
    February 20, 2011
    Date of Event
    February 20, 2011
    Report Date
    February 20, 2011
    Manufacturer
    INSULET CORP.
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    OMNIPOD POD FAILED AND ALARMED AFTER ONLY 23 HOURS OF USE. WIRELESS CONTROLLER IDENTIFIED POD FAILURE AS CAUSE FOR ALARM AND PROVIDED REFERENCE NUMBER (B)(4). AFTER POD SN (B)(4) ALARMED, IT WAS SWITCHED FOR A NEW POD (B)(4) LOT NUMBER 30381. THIS POD FAILED AND ALARMED DURING THE PRIMING PROCESS AND PROVIDED THE SAME ERROR REFERENCE CODE (B)(4) AS LISTED ON THE PREVIOUS POD FAILURE. THE TWO FAILURES OCCURRED WITHIN 30 MINUTES OF EACH OTHER TODAY AND ONLY 23 HOURS AFTER THE PREVIOUS POD FAILURE WHICH THIS WRITER HAS ALSO REPORTED TO MEDWATCH. INSULET CORP EMPLOYEES HAVE BEEN OFFERED THE DEFECTIVE PODS AND THIS WRITER HAS SIMPLY BEEN INSTRUCTED TO DISPOSE OF THE DEVICES AS THE COMPANY DOES NOT REQUIRE THEM FOR ANALYSIS. (SAME PT AS (B)(4).)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN MANAGEMENT SYSTEM OMNIPOD INSULIN POD LZG INSULET CORP. L30381
    2 OMNIPOD INSULIN MANAGEMENT SYSTEM OMNIPOD INSULIN POD LZG INSULET CORP. 30381

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability