BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3222874 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10458
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS TO REPORT THAT ON (B)(6) 2013, THE PATIENT EXPERIENCED THE SYMPTOMS OF VOMITING AND DEHYDRATION, AND WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF DKA. THE PATIENT¿S ADMITTING BLOOD GLUCOSE LEVEL WAS ¿GREATER THAN 300 MG/DL¿. NO TROUBLESHOOTING COULD BE DONE AT THE TIME OF THE CALL, AND THE PATIENT WAS NOT AVAILABLE DURING FOLLOW UP ATTEMPTS. NO INFORMATION WAS PROVIDED ABOUT THE PATIENT¿S STATUS PRIOR TO THE HOSPITAL ADMISSION, HIS TECHNIQUE, INSULIN OR PUMP STATUS. AS THE PATIENT REPORTEDLY WAS HOSPITALIZED WITH DKA WHILE USING THE INSULIN PUMP THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324448 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L