BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2201278 · Received August 11, 2011

    Report

    Report Number
    2531779-2011-05790
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE UP AND CONTRAST BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE CONTRAST BUTTON HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE KEYPAD WAS REMOVED AND CORROSION WAS OBSERVED UNDER THE BUTTON CONTACTS. UNRELATED TO THIS COMPLAINT, THE DISPLAY WAS FOUND TO BE FADED AND DISCOLORED AND THE DISPLAY LENSE WAS FOUND TO LEAK. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THIS REPORT IS MADE 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. (B)(6).

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE UP ARROW BUTTON WAS NOT RESPONDING. THE FAMILY MEMBER REPORTED THAT THERE WAS NO TRAUMA TO THE PUMP; THE PUMP WAS EXPOSED TO POOL WATER. THE PATIENT REPORTEDLY WORE THE PUMP IN A PUMP SKIN IN AN UNDERGARMENT AND DID NOT CLEAN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR