BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2080156 · Received April 6, 2011

    Report

    Report Number
    2531779-2011-02322
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    July 1, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVAL HAS NOT YET BEEN COMPLETED. WHEN EVAL IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    KEYPAD BUTTON PRESSES DO NOT ACTIVATE INTENDED PUMP RESPONSE. THE PT REPORTED THAT THE KEYPAD BUTTONS HAVE BEEN INTERMITTENTLY OVER RESPONDING AND NOT RESPONDING FOR THE PAST 9 MONTHS. SHE NOTED THAT THE KEYPAD BUTTONS FEEL FLAT. THE PT CONFIRMED THAT THE RUBBER KEYPAD IS INTACT; DENIED EXPOSING THE PUMP TO WATER AND CLEANING PRODUCTS; AND STATED THAT SHE WEARS THE PUMP IN HER BRA OR 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 CORP. ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR