BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2063211 · Received April 12, 2011

    Report

    Report Number
    2531779-2011-02473
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE STICKING AND INTERMITTENTLY UNRESPONSIVE. THE PATIENT REPORTED THAT THE KEYPAD BUTTONS HAVE BECOME SLOW TO RESPOND OVER THE PAST MONTH, AND LAST WEEK, THE KEYPAD BUTTONS STARTED STICKING INTERMITTENTLY. HE NOTED THAT THE BUTTONS REQUIRE EXCESSIVE FORCE AND MULTIPLE PRESSES TO OBTAIN A RESPONSE. THE PATIENT STATED THAT THE BUTTONS STILL CLICK AND SPRING BACK WHEN PRESSED. HE DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED EXPOSING THE PUMP TO WATER AND CLEANING PRODUCTS; AND STATED THAT HE WEARS THE PUMP IN VARIOUS PLACES 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 22 YR