BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2091224 · Received April 20, 2011

    Report

    Report Number
    2531779-2011-02707
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 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 NOT BEEN RETURNED TO ANIMAS. 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. THE PT REPORTED THAT THE UP ARROW KEYPAD BUTTONS STOPPED WORKING A FEW MINUTES AGO. HE NOTED THAT THE BUTTON STILL SPRINGS BACK WHEN PRESSED. THE PT STATED THAT THE KEYPAD IS WORN BUT INTACT. HE DENIED EXPOSING THE PUMP TO MOISTURE, AND STATED THAT HE WEARS THE PUMP IN HIS POCKET OR ON HIS WAIST.

    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 42 YR