BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3212972 · Received July 9, 2013

    Report

    Report Number
    2531779-2013-09954
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING THAT THE KEYPAD BUTTONS WERE UNRESPONSIVE. THE PATIENT REPORTEDLY PEELED BACK THE RUBBER AROUND THE UP AND DOWN ARROW KEYPAD BUTTONS TO GET THE BUTTONS TO RESPOND. THERE WAS REPORTEDLY NO DAMAGE TO THE KEYPAD PRIOR TO THE PATIENT PEELING BACK THE KEYPAD. THE PATIENT DENIED EXPOSING THE PUMP TO WATER AND DENIED TRAUMA TO PUMP. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313314 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR