BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3243876 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11781
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/02/2013 WITH THE FOLLOWING FINDINGS: ALL OF THE KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND FOUND CONTAMINATION UNDER ALL OF THE BUTTON CONTACTS. IN ADDITION TO THE KEYPAD CONTAMINATION, MOISTURE WAS EVIDENT BEHIND THE PUMP DISPLAY SCREEN LENS. A LEAK TEST WAS PERFORMED AND FOUND THAT THE PUMP WAS LEAKING FROM A CRACK NEAR THE BOTTOM OF THE DISPLAY LENS. THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS OBSERVED THROUGHOUT THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE KEYPAD BUTTONS WERE NOT RESPONSIVE TO USER PRESSES. THE ISSUE WAS DETECTED WHEN THE PATIENT WAS DISCONNECTED FROM THE DEVICE AND THE BATTERY WAS BEING REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE KEYPAD ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343421 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR