BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3874762 · Received June 16, 2014

    Report

    Report Number
    2531779-2014-17119
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED FOR RETURN 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 A HYPOGLYCEMIC EVENT DUE TO AN INADVERTENT INFUSION ISSUE. THE PATIENT REPORTEDLY HAD BLOOD GLUCOSE (BG) READING OF 20 MG/DL AND FELT REALLY TIRED. NO TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT WAS REPORTED AND THE PATIENT HAD REMAINED ON PUMP THERAPY. IT WAS REPORTED THAT THE PATIENT RECEIVED ABOUT 30 UNITS OF EXCESS INSULIN DUE TO THE UNLOCKED KEYPAD BUTTONS BEING PRESSED INADVERTENTLY. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGED SERIOUS HYPOGLYCEMIC EVENT ATTRIBUTED TO USE ERROR RESULTING IN UNINTENDED DELIVERY OF EXCESS INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352537 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening