BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2060759 · Received April 8, 2011

    Report

    Report Number
    2531779-2011-02209
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    February 12, 2011
    Report Date
    March 5, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DOWN ARROW KEYPAD BUTTON HAS BEEN INTERMITTENTLY UNRESPONSIVE FOR THE (B)(6). HE NOTED THAT THE OK BUTTON SYMBOL IS WORN, AND THAT THE BUTTONS STILL SPRING BACK AS EXPECTED WHEN PRESSED. THE FAMILY MEMBER DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED THAT THE PUMP HAS BEEN EXPOSED TO CLEANING PRODUCTS; AND STATED THAT THE PATIENT WEARS THE PUMP ON HER WAIST IN A POUCH.

    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 5 YR