BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2223634 · Received August 25, 2011

    Report

    Report Number
    2531779-2011-06217
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS 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 KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. THE KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE DURING TESTING. DURING INVESTIGATION, EVIDENCE OF KEYPAD ADHESIVE WAS FOUND UNDER ALL KEY CONTACTS. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL KEYPAD BUTTONS (UP ARROW, DOWN ARROW, OKAY, AND CONTRAST) WERE UNRESPONSIVE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE ABOUT THIS COMPLAINT.

    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