BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2200119 · Received August 10, 2011

    Report

    Report Number
    2531779-2011-05760
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. 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. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE DOWN ARROW AND OK BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONSIVE. WHEN THE RUBBER KEYPAD WAS REMOVED, THE CONTACTS WERE FOUND TO BE MISALIGNED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP HAD UNRESPONSIVE DOWN ARROW AND OK BUTTONS. THERE WAS NO ADDITIONAL INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1200 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1