BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2181850 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05379
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    July 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: ALL KEYPAD BUTTONS WERE NOT RESPONSIVE. THERE WAS NO PHYSICAL DAMAGE TO THE KEYPAD OR PUMP CASE. DISPLAY LENS HAD MOISTURE. AN IN-HOUSE LEAK TEST REVEALED A DISPLAY LENS LEAK ISSUE. THERE WAS MOISTURE RESIDUE ON THE INTERNAL COMPONENTS AND PC BOARD. 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. (B)(6).

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED KEYPAD ISSUE. REPORTEDLY, THE KEYPAD BUTTONS DO NOT RESPOND AFTER THE PATIENT WENT FOR A SWIM. IT WAS NOTED THE SCREEN HAD MOISTURE. THE ISSUE WAS NOT RESOLVED WITH TRAINING. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE ANIMAS PRODUCT IS BEING RETURNED FOR INVESTIGATION. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR