BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2081674 · Received May 9, 2011

    Report

    Report Number
    2531779-2011-03223
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    A FAMILY MEMBER REPORTED THAT THE UP ARROW AND DOWN ARROW KEYPAD BUTTONS HAVE BEEN INTERMITTENTLY UNRESPONSIVE FOR THE PAST MONTH. SHE NOTED THAT THE KEYPAD IS NOW TORN. THE FAMILY MEMBER DENIED EXPOSING THE PUMP TO MOISTURE, AND STATED THAT THE PATIENT CARRIES THE PUMP IN A POUCH. AT THE TIME OF THE COMPLAINT, THE PATIENT CHOSE TO KEEP THE PUMP; THERE HAVE BEEN NO FURTHER REPORTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1200 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR