BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3141280 · Received June 3, 2013

    Report

    Report Number
    2531779-2013-07462
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DISREGARD MDR # 2531779-2013-07462, AS IT WAS INADVERTENTLY SUBMITTED. THE COMPLAINT HAS BEEN REPORTED UNDER MDR # 2531779-2013-07723 AND ANY ADDITIONAL INFORMATION OR INVESTIGATION RESULTS WILL BE SUBMITTED AS A SUPPLEMENTAL UNDER MDR # 2531779-2013-07723.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD ISSUE. IT WAS REPORTED THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS NOT BEING REPORTED BECAUSE THE CONTRAST BUTTON AND WORN KEYPAD SYMBOLS HAVE NO EFFECT ON INSULIN DELIVERY FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244394 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR