BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2051867 · Received March 14, 2011

    Report

    Report Number
    2531779-2011-01545
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    January 1, 2010
    Report Date
    February 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: ALL KEYPAD BUTTONS WERE FOUND TO BE RESPONDING APPROPRIATELY. THE BOLUS BUTTON WAS REMOVED AND NO ISSUES WERE FOUND WITH THE BUTTON CONTACT. UNRELATED TO THE COMPLAINT, THE KEYPAD SYMBOLS WERE FOUND TO BE WORN, THIS ISSUE HAS NO EFFECT ON INSULIN DELIVERY FUNCTION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. THE PUMP IS OUT OF WARRANTY AND THE PT HAS CHOSEN TO CONTINUE USING THE DEVICE AT THIS TIME. 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. THE PT REPORTED THAT THE EZBOLUS BUTTON HAS REQUIRED ADDITIONAL PRESSES WITH EXCESSIVE FORCE TO OBTAIN A RESPONSE FOR THE PAST SEVERAL MONTHS. HE NOTED THAT THE EZBOLUS BUTTON COVER IS INTACT, AND THE BUTTON FEELS FLAT AND HARD. THE PT STATED THAT THE OK BUTTON SYMBOL IS WORN, BUT ALL KEYPAD BUTTONS RESPOND AS EXPECTED EXCEPT FOR THE EZBOLUS BUTTON. HE DENIED THAT THE PUMP HAS BEEN EXPOSED TO WATER AND CLEANING PRODUCTS, AND STATED THAT HE WEARS THE PUMP ATTACHED TO HIS POCKET WITH A CLIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR