BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS 2020

    MDR report key: 2903765 · Received January 7, 2013

    Report

    Report Number
    MW5028448
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ANIMAS
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THAT IN (B)(6) 2012, ANIMAS SENT HER A LETTER INFORMING HER THAT THE SOFTWARE OF HER ANIMAS2020 INSULIN PUMP WILL EXPIRE IN 12/15. THE LETTER ALSO STATED THAT ON 12/31/2015 HER PUMP WILL CEASE DELIVERING INSULIN. WHEN SHE PURCHASED THIS PUMP THERE WAS NO NOTIFICATION OR LABELING THAT INDICATED THE PUMP WILL EXPIRE AFTER A CERTAIN PERIOD OF TIME, NEITHER WAS SHE PROVIDED ANY EDUCATION ABOUT THIS. REPORTER BLAMES THE MANUFACTURER FOR NOT PROVIDING ENOUGH WARNING TO THE PUBLIC ABOUT AN EXPIRATORY DATE ON THEIR PRODUCT BEFORE SELLING THEM TO THE PUBLIC. SHE MENTIONED THAT THESE PUMPS ARE VERY EXPENSIVE AND HOPES THAT THE GOVERNMENT AND THE FDA IN PARTICULAR CAN LOOK INTO THIS ISSUE AND ENFORCE REGULATIONS AND SAVE THE PUBLIC FROM MANUFACTURERS LIKE ANIMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7924 ANIMAS 2020 INSULIN PUMP LZG ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1