BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3972698 · Received August 1, 2014

    Report

    Report Number
    2531779-2014-22049
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    May 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/14/2014 WITH THE FOLLOWING FINDINGS: THERE WAS NO VISIBLE DAMAGE THE KEYPAD. THE KEYPAD BUTTONS WERE TESTED AND THE BUTTONS WERE FOUND TO BE RESPONDING PROPERLY TO PRESSES. THE KEYPAD WAS REMOVED AND NO CONTAMINATION WAS FOUND UNDER THE KEYPAD BUTTON CONTACTS. DURING TESTING, THE PUMP WAS FOUND TO BE LEAKING FROM A DAMAGED BOLUS BUTTON. THE PUMP WAS OPENED AND CORROSION WAS OBSERVED ON THE KEYPAD FLEX AND CONNECTION TO THE PRINTED CIRCUIT BOARD.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PUMP KEYPAD WAS NOT RESPONDING TO BUTTON PRESSES. THE REPORTER INDICATED THAT THE PUMP WAS STUCK ON THE HOME SCREEN BUT THE BUTTON PRESSES WERE CAUSING THE DISPLAY TO GET BRIGHTER BUT THERE WAS NOTHING ELSE. THE REPORTER INDICATED THAT THE PUMP HAD BEEN EXPOSED TO MOISTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450608 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR