BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2113073 · Received June 3, 2011

    Report

    Report Number
    2531779-2011-03900
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: EVALUATION FOUND THAT THE PUMP POWERS UP PROPERLY. POWER FLEX, CIRCUIT BOARD, AND TERMINAL CONNECTIONS WERE FOUND TO BE INTACT. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO RE-BOOTS OCCURRING. A REVIEW OF PUMP HISTORY INDICATED THAT PUMP HAD REBOOTED WHICH WAS NOT DUPLICATED DURING TESTING. THE CONTRAST BUTTON WAS FOUND TO NOT SPRING BACK AS NORMAL. THE CONTRAST BUTTON HAS NO EFFECT ON THE PUMP'S INSULIN DELIVERY FUNCTION. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER ALL OF THE KEYPAD BUTTON CONTACTS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP KEEPS REBOOTING AND GOING BACK TO THE VERIFY SCREEN. SHE STATED THAT SHE REPLACED THE BATTERY. THE PATIENT ALSO STATED THAT KEYPAD BUTTONS ARE HARD TO PRESS AND NOT RESPONDING APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR