BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2041548 · Received March 10, 2011

    Report

    Report Number
    2531779-2011-01499
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVAL REVEALED THAT THE UP ARROW KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. ALL OTHER KEYPAD BUTTONS WERE FOUND TO BE RESPONSIVE AS EXPECTED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER THE UP ARROW BUTTON KEY CONTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE STICKING AND INTERMITTENTLY UNRESPONSIVE. THE PT REPORTED THAT THE UP ARROW BUTTON HAS BEEN STICKING AND INTERMITTENTLY UNRESPONSIVE FOR A FEW WEEKS. SHE NOTED THAT THE KEYPAD BUTTONS CLICK AND SPRING BACK AS EXPECTED. THE PT DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED THAT THE PUMP HAS BEEN EXPOSED TO WATER; AND STATED THAT SHE WEARS THE PUMP IN VARIOUS PLACES WITH A CLIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR