BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2091609 · Received May 17, 2011

    Report

    Report Number
    2531779-2011-03464
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: NO DAMAGE WAS OBSERVED TO THE KEYPAD. THE KEYPAD BUTTONS WERE FOUND TO BE RESPONDING APPROPRIATELY TO BUTTON PRESSES. THE KEYPAD WAS REMOVED AND NO DAMAGE WAS OBSERVED TO THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED, THERE WAS CORROSION IN THE BATTERY COMPARTMENT, AND MOISTURE DAMAGE WAS FOUND INSIDE THE PUMP.

    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. (B)(6).

    Description of Event or Problem · 1

    THE MOTHER OF THE PATIENT REPORTED THAT THE BUTTONS ARE NOT RESPONDING ANYMORE. SHE REPORTED THERE WAS MOISTURE IN THE BATTERY COMPARTMENT. THE PATIENT WEARS THE PUMP WHILE SWIMMING.

    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 11 YR