BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2091253 · Received April 20, 2011

    Report

    Report Number
    2531779-2011-02729
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    November 25, 2010
    Report Date
    March 25, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PT REPORTED THAT THE DOWN ARROW KEYPAD BUTTON HAS BEEN INTERMITTENTLY UNRESPONSIVE FOR THE PAST 4 MONTHS. SHE NOTED THAT THE DOWN ARROW BUTTONS FEELS MUSHY AND DOES NOT CLICK WHEN PRESSED, AND THAT THE OK BUTTON SYMBOL IS WORN. THE PT DENIED PHYSICAL DAMAGE TO THE KEYPAD; DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT SHE CARRIES THE PUMP IN A PUMP SKIN IN HER POCKET.

    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 56 YR