BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3830074 · Received May 23, 2014

    Report

    Report Number
    2531779-2014-14683
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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) 2014 THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT HAD EXPERIENCED BLOOD GLUCOSE (BG) OF 380MG/DL WITH SMALL KETONES AND NAUSEA ASSOCIATED WITH RECURRING OCCLUSION ALARMS. THE REPORTER NOTED THAT A BOLUS WAS CANCELLED DUE TO AN OCCLUSION ALARM AND THAT THE OCCLUSION ALARM ISSUE HAD CONTINUES DESPITE CHANGING INFUSION SETS. THE ALLEGED BG EXCURSION DOES NOT MEET CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PUMP WAS EMITTING RECURRING OCCLUSION ALARMS AND THE ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308453 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR