BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2041568 · Received March 10, 2011

    Report

    Report Number
    2531779-2011-01497
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 13, 2011
    Report Date
    February 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. THE PUMP IS OUT OF WARRANTY, AND THE PT HAS CHOSEN TO CONTINUE USING THE DEVICE AT THIS TIME. IF THE DEVICE IS RETURNED, AN EVAL 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 BUTTONS WERE UNRESPONSIVE. A FAMILY MEMBER REPORTED THAT A REMINDER WAS REC'D ON THE DISPLAY SCREEN, BUT THERE WAS NO RESPONSE WHEN THE OK KEYPAD BUTTON WAS PRESSED. THE PUMP WAS DISCONNECTED FROM THE PT AND REBOOTED, AND THE FAMILY MEMBER WAS THEN ABLE TO OBTAIN A RESPONSE FROM THE OK BUTTON WITH SEVERAL PRESSES. SHE NOTED THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS RESPONDED APPROPRIATELY. THE FAMILY MEMBER STATED THAT THE KEYPAD BUTTONS BOUNCE AND SPRING BACK AS EXPECTED. SHE REPORTED LATER THE SAME DAY THAT THE OK KEYPAD BUTTON WAS COMPLETELY UNRESPONSIVE. SHE DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD, AND STATED THAT THE PT WEARS THE PUMP ON HER WAIST WITH A CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION IR1250

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR