BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2070860 · Received April 15, 2011

    Report

    Report Number
    2531779-2011-02594
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    February 1, 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
    IN, US
    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 CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE LETTERING ON THE KEYPAD HAS WORN OFF BUT THE RUBBER KEYPAD COVER WAS INTACT. ALL KEYPAD BUTTONS RESPONDED TO PRESSES APPROPRIATELY. THE KEYPAD WAS REMOVED AND ADHESIVE WAS FOUND UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PT REPORTED THAT THE KEYPAD BUTTONS HAVE NOT RESPONDED PROPERLY FOR THE PAST SEVERAL WEEKS. SHE CONFIRMED THAT THERE IS NO STRUCTURAL DAMAGE, BUT NOTED THAT THE KEYPAD SYMBOLS ARE WORN. THE PT DENIED EXPOSING THE PUMP TO WATER AND CLEANING PRODUCTS, AND STATED THAT SHE WEARS THE PUMP IN HER POCKET.

    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 31 YR