BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1942798 · Received December 20, 2010

    Report

    Report Number
    2531779-2010-02984
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Report Date
    November 21, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THE REPORT IS UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 SUBMITTED: 09/07/2012 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: ON INVESTIGATION, THE KEYPAD WAS FOUND TO BE FULLY INTACT WITHOUT PEELING OR VISIBLE DAMAGE. ON TESTING, THE OK BUTTON WAS INTERMITTENTLY UNRESPONSIVE. THE AUDIO BOLUS BUTTON WAS UNRESPONSIVE. ALL REMAINING KEYPAD BUTTONS RESPONDED APPROPRIATELY. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACTS OF ALL THE KEYPAD BUTTONS, INCLUDING THE AUDIO BOLUS BUTTON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE UP AND DOWN ARROW KEYPAD BUTTONS REPORTEDLY HAVE TO BE PRESSED SEVERAL TIMES FOR A RESPONSE. THE PT CLAIMED THAT THE BUTTONS ARE NOT STICKING, CONTINUE TO MAKE A CLICKING SOUND WHEN PRESSED AND THE KEYPAD IS INTACT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1250

    Patients

    Seq Age Sex Outcome Treatment
    1