BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2031823 · Received March 21, 2011

    Report

    Report Number
    2531779-2011-01780
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. THE DOWN KEYPAD BUTTON WAS INTERMITTENTLY RESPONSIVE DURING TESTING. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER THE DOWN ARROW AND OK BUTTONS. UNRELATED TO THE COMPLAINT, DURING EVALUATION A CRACKED BATTERY COMPARTMENT WAS OBSERVED, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS,CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. IT WAS ALSO OBSERVED THAT THE DISPLAY SCREEN HAD A DIM REDDISH TINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOWN ARROW BUTTON IS SLOW TO RESPOND. IT WAS REPORTED THE KEYPAD IS INTACT AND THE PUMP IS NOT EXPOSED TO MOISTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1