BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS

    MDR report key: 1642625 · Received March 23, 2010

    Report

    Report Number
    MW5015285
    Event Type
    Injury
    Date Received
    March 23, 2010
    Date of Event
    March 23, 2010
    Report Date
    March 23, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ANIMAS INSULIN PUMP 1250. THIS DEVICE, AN INSULIN PUMP IS CRITICALLY IMPORTANT TO A DIABETIC. UNFORTUNATELY, MY PUMP HAS FAILED, AND HAD TO BE REPLACED, TWICE WITHIN THE LAST FOUR YEARS. ANIMAS CORP MAINTAINS THAT THE DEVICE SHOULD LAST FOUR YRS AND HAS OFFERED NO EXPLANTATION FOR THE FAILURES. THE PUMP CARRIES A FOUR-YEAR MFR WARRANTY. THE ORIGINAL PUMP WAS PURCHASED IN (B) (6) 2006. THAT PUMP LASTED ONLY 9 MONTHS, UNTIL (B) (6) 2006. A REPLACEMENT PUMP LASTED FOR ANOTHER YEAR AND A HALF, UNTIL (B) (6) 2008. THIS SECOND PUMP WAS THEN REPLACED WITH A THIRD. THE THIRD PUMP IS NOW FAILING, AFTER A LITTLE MORE THAN A YEAR AND A HALF OF USE. THREE PUMP FAILURES WITHIN SUCH A SHORT PERIOD OF TIME RAISES A CONCERN ABOUT THE ADEQUACY OF THE MFR'S TESTING AND LABELING. AN UNEXPECTED INSULIN PUMP FAILURE CAN LEAD TO A SERIOUS DIABETIC REACTION OR WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS IR 1250 INSULIN PUMP LZG ANIMAS CORPORATION 1250

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability