BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2041616 · Received March 10, 2011

    Report

    Report Number
    2531779-2011-01458
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 9, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS, AS THE PUMP IS OUT OF WARRANTY AND THE PT HAS CHOSEN TO CONTINUE USING THE PUMP AT THIS TIME. 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

    THE PT REPORTED THAT THE KEYPAD BUTTONS HAVE BEEN INTERMITTENTLY UNRESPONSIVE FOR THE PAST WEEK. HE NOTED THAT THE BUTTONS CLICK AND SPRING BACK, BUT REQUIRE EXCESSIVE FORCE TO OBTAIN A RESPONSE. THE PT DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED THAT THE PUMP HAS BEEN EXPOSED TO CLEANING PRODUCTS; AND STATED THAT HE WEARS THE PUMP ON HIS WAIST WITH A HOLSTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1250

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR