BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2070848 · Received April 15, 2011

    Report

    Report Number
    2531779-2011-02593
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    January 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DIETICIAN

    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 DIETICIAN REPORTED THAT ALL KEYPAD BUTTONS HAVE BEEN INTERMITTENTLY UNRESPONSIVE FOR THE PAST TWO MONTHS. SHE NOTED THAT THE BUTTONS CLICK AND SPRING BACK AS EXPECTED WHEN PRESSED. THE DIETICIAN CONFIRMED THAT THE KEYPAD IS INTACT; STATED THAT THE PT WEARS THE PUMP IN HIS POCKET; AND NOTED THAT THE PT DROPS THE PUMP FREQUENTLY. SHE REPORTED THAT THE PT HAS CHOSEN TO CONTINUE USING THE PUMP AT THIS TIME.

    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 15 YR