BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3874690 · Received June 16, 2014

    Report

    Report Number
    2531779-2014-17110
    Event Type
    Injury
    Date Received
    June 16, 2014
    Report Date
    June 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING A HISTORY SETTINGS (TIME AND DATE RESET) ISSUE. THIS IS BEING RULED OUT BASED ON THE FOLLOWING: THE PATIENT STATED THAT THE TIME AND DATE DEFAULTED TO FACTORY SETTINGS AFTER THE BATTERY WAS REPLACED. THE PUMP DISPLAYS THE VERIFY SCREEN AFTER IT IS REBOOTED AND THE TIME AND DATE MUST BE SET TO CONFIRM THE VERIFY SCREEN. THE ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT. THE REPORTER STATED THAT THE PATIENT¿S BLOOD GLUCOSE (BG) WAS 600MG/DL WITH INCREASED THIRST AND URINATION, WEAKNESS, VOMITING AND LARGE KETONES. THE PATIENT WAS TREATED WITH INSULIN VIA PUMP AND INJECTION. THE PATIENT DID NOT RECEIVE ANY EMERGENCY CARE. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352929 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening