BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2160149 · Received July 13, 2011

    Report

    Report Number
    2531779-2011-04894
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 13, 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

    (B)(6). 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. THE OK BUTTON CONTACT WAS OBSERVED TO BE INVERTED. UNRELATED TO THE KEYPAD BUTTON COMPLAINT, INVESTIGATION FOUND THAT BOLUS BUTTON HAD A HOLE IN IT AND WAS DIFFICULT TO PRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MUST PRESS SEVERAL TIMES ON THE BUTTONS TO GET THEM TO WORK. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE ABOUT THIS COMPLAINT. THE COMPLAINT IS BEING REPORTED BECAUSE UNRESPONSIVE BUTTONS HAVE BEEN KNOWN ON OCCASION TO CONTRIBUTE TO A PATIENT EVENT.

    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