BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3151585 · Received June 7, 2013

    Report

    Report Number
    2531779-2013-07884
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED FO RETURN AT THIS TIME. 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 HAD BEEN EXPERIENCING FREQUENT ELEVATED BLOOD GLUCOSE (BG) UP TO 500 MG/DL WITH NO SYMPTOMS, AND HAS BEEN OFF THE PUMP FOR ABOUT TWO WEEKS DUE TO DIFFICULTY CONTROLLING BGS. THE REPORTER DID NOT BLAME THE PUMP, STATING THERE WERE SEVERAL FACTORS CONTRIBUTING TO BG EXCURSIONS, INCLUDING PUBERTY, GROWTH SPURTS, AND NON-COMPLIANCE. THE REPORTER NOTED THAT THE PATIENT HAS BEEN EATING A LOT LATELY DUE TO GROWTH SPURTS. THE REPORTER STATED THAT THE PATIENT TREATS BG ELEVATIONS WITH SYRINGE INJECTIONS AND BG RESPONDS. THE PATIENT WAS REPORTEDLY ON AN ALTERNATE PLAN FOR INSULIN DELIVERY AT THE TIME OF THE CALL TO ANIMAS. THE REPORTER RE-ITERATED THAT SHE DID NOT BELIEVE THE PUMP WAS AN ISSUE. THE PATIENT WAS TO RE-START INSULIN PUMP THERAPY BUY WAS TO RECEIVE ADDITIONAL TRAINING BEFORE RE-STARTING THE PUMP. THE REPORTER ALSO NOTED THEY ARE IN CONTACT WITH THE PATIENT¿S HEALTHCARE PROVIDER TO DISCUSS TRYING DIFFERENT INFUSION SETS. CUSTOMER TECHNICAL SUPPORT REVIEWED THE PUMP WITH THE REPORTER AND FOUND ALL SETTINGS AND HISTORIES WERE CORRECT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY WITH NON-COMPLIANCE AS A REPORTED POTENTIAL CONTRIBUTOR; IT WAS UNCLEAR AT THE TIME OF INITIAL CONTACT IF THE NON-COMPLIANCE WAS ASSOCIATED WITH USE OF THE PUMP OR WITH GENERAL DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253087 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Life Threatening