BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3103043 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06110
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 14, 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

    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. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT'S BLOOD GLUCOSE (BG) WAS 558 MG/DL AND THE PUMP ALARMED THAT IT HAD EXCEEDED THE DAILY MAXIMUM LIMIT (MAX TDD). CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE PUMP HISTORY WITH THE REPORTER AND CONFIRMED ALL THE EVENING BOLUSES PROGRAMMED HAD BEEN RECEIVED. THE REPORTER NOTED THAT THE PATIENT HAD BEEN BOLUSING MORE DUE TO HIGH CARBOHYDRATE MEALS AND CONFIRMED THAT THE PATIENT'S BG RESPONDED TO BOLUSES. CTS ADVISED THE REPORTER THAT AT MIDNIGHT THE TDD WOULD RE-SET AND BOLUSES COULD BE DELIVERED AGAIN. CTS ALSO REVIEWED CHANGING THE MAX TDD LIMITS ON THE PUMP. CTS ADVISED THE REPORTER IF BGS DO NOT COME DOWN OR IF THERE ARE ANY OTHER ISSUES, TO CALL BACK. THE PUMP WAS FOUND TO BE ALARMING APPROPRIATELY ACCORDING TO SETTINGS AND THERE WAS NO DEFECT FOUND DURING TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY DUE TO EXCEEDING THE MAXIMUM DAILY INSULIN DELIVERY LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203432 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening