BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3834090 · Received May 27, 2014

    Report

    Report Number
    2531779-2014-14878
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 06/02/2014-ADDITIONAL INFORMATION:THE REPORTER CONTACTED ANIMAS ON 05/30/2014 WITH THE FOLLOWING ADDITIONAL INFORMATION:IT WAS REPORTED THAT THE UP ARROW KEYPAD BUTTON WAS OVER RESPONSIVE, AND THAT THE OK AND DOWN ARROW KEYPAD BUTTONS WERE UNDER RESPONSIVE TO USER PRESSES.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. THERE WAS NO FURTHER INFORMATION AVAILABLE REGARDING THE COMPLAINT AT THIS TIME; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF A KEYPAD BUTTON RESPONSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311490 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR