BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3101883 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06065
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE (BG) UP TO 521MG/DL WITH NO REPORTED SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE BGS WERE REPORTEDLY TREATED WITH BOLUSES VIA THE PUMP. THE REPORTER NOTED A PATTERN IN THE BG ELEVATIONS, OCCURRING IN THE LATE AFTERNOONS TO EVENINGS. THE REPORTER STATED THAT THE PATIENT HAS BEEN ON NEW OTC MEDICATION FOR GI DISTRESS IN THE PAST TWO WEEKS AND WAS WONDERING IF THAT COULD BE CAUSING THE BG ELEVATIONS. THE REPORTER STATED THE PATIENT'S HEALTHCARE PROVIDER (HCP) HAD NOT BEEN CONSULTED REGARDING THE GI DISTRESS. THE REPORTER NOTED THAT SITES ARE CHANGED EVERY TWO DAYS, AND CONFIRMED ALL PUMP SETTINGS AND HISTORIES WERE CORRECT. TROUBLESHOOTING INDICATED THE PUMP WAS DELIVERING APPROPRIATELY. THE REPORTER WAS ADVISED TO FOLLOW UP WITH THE PATIENT'S HCP TO DISCUSS THE PATTERN OF BG ELEVATIONS AND THE POSSIBLE NEED FOR SETTINGS ADJUSTMENTS. THE PUMP IS NOT BEING RETURNED AT THIS TIME AND THE PATIENT CONTINUED INSULIN PUMP THERAPY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA OF UNCLEAR CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204530 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening