BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2050456 · Received April 5, 2011

    Report

    Report Number
    2531779-2011-02271
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    September 7, 2010
    Report Date
    March 7, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. A FAMILY MEMBER REPORTED THAT THE OK KEYPAD BUTTON HAS REQUIRED SEVERAL HARD PRESSES TO OBTAIN A RESPONSE OVER THE (B)(6). SHE DENIED DAMAGE TO THE RUBBER KEYPAD, BUT NOTED THAT THE AUDIO BOLUS BUTTON COVER IS TORN. THE FAMILY MEMBER DENIED EXPOSING THE PUMP TO WATER; AND STATED THAT THE PATIENT CARRIES THE PUMP IN A CASE IN A CUP HOLDER ON HIS WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1200

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR