BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3881667 · Received June 18, 2014

    Report

    Report Number
    2531779-2014-17481
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT 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) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING BLOOD GLUCOSE LEVELS RANGING FROM BELOW 70 MG/DL WITH SYMPTOMS OF AGGRESSION AND HYPERACTIVITY TO OVER 250 MG/DL ASSOCIATED WITH AN ALLEGATION OF INACCURATE DELIVERY. THE PUMP WAS REVIEWED WITH THE REPORTER AND CONFIRMED THAT THE TIME AND DATE WERE CORRECT, THE PUMP BASAL AND BOLUS SETTINGS WERE PROGRAMMED CORRECTLY, THE BASAL HISTORY REFLECTED THE BASAL PROGRAM AND MATCHED THE BASAL TOTAL IN THE TOTALLY DAILY DOSE, AND THE BOLUSES WERE RECORDED AS PROGRAMMED AND THE BOLUS TOTALS MATCHED. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH AN ALLEGATION OF INACCURATE DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358095 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Life Threatening