BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1893669 · Received November 2, 2010

    Report

    Report Number
    2531779-2010-02032
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. 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

    IT WAS REPORTED THAT THE KEYPAD IS TORN OVER THE UP ARROW AND THE BRASS BUTTON IS EXPOSED. THE PATIENT STATED THAT SHE NEEDED TO PRESS EXTRA HARD TO GET THE UP ARROW BUTTON TO RESPOND. THE OTHER KEYPAD BUTTONS ARE RESPONSIVE. SHE NOTED THAT THE PROBLEM BEGAN ABOUT ONE MONTH AGO, THE TORN AREA HAS GOTTEN LARGER OVER TIME, AND SHE IS UNSURE HOW THE TEAR BEGAN. THE PATIENT REPORTED THAT SHE DOES NOT EXPOSE THE PUMP TO WATER OR CLEANING SOLVENTS, SHE WEARS THE PUMP WITH A CLIP, AND SHE USES THE FINGER PAD TO PRESS THE BUTTONS. SHE STATED THAT SHE FEELS THE UP ARROW BUTTON CLICK AND SPRING BACK SOMETIMES BUT NOT ALWAYS. THE PATIENT CONFIRMED THAT THE PUMP IS USABLE WITH MONITORING OF THE BUTTON PRESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR