BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3000231 · Received March 12, 2013

    Report

    Report Number
    2531779-2013-02623
    Event Type
    Injury
    Date Received
    March 12, 2013
    Report Date
    February 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PATIENT WAS IN THE HOSPITAL FOR DIABETIC KETOACIDOSIS. THE REPORTER CALLED IN TO CHECK ACCURACY OF THE PUMP. THE REPORTER STATED THAT THE BATTERY WAS REMOVED FROM THE WHEN SHE WAS ADMITTED TO THE HOSPITAL. CUSTOMER SUPPORT (CS) REVIEWED HISTORY SETTINGS INDICATED THAT THE PUMP WAS SUSPENDED WITH CORRECT DATE AND TIME AND RESUMED WITH 2007 DATE AND TIME. THIS REPORT IS BEING MADE DUE TO THE ALLEGED HYPERGLYCEMIC EVENT THAT THE PATIENT EXPERIENCED DUE TO THE ALLEGED HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103543 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization