BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242815 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11734
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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¿S BLOOD GLUCOSE (BG) ALWAYS LOW 40 AND 50 MG/DL SINCE STARTING ON THIS PUMP WITH FEELING SHAKY, HYPER AND PALE. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THE REPORTER STATED THAT THEY HAVE DECREASED THE BASAL TO ALMOST NOTHING. THE REPORTER STATED THAT THE PATIENT DOES NOT BOLUS AT MEALS AND PATIENT IS STILL RUNNING LOW. THE REPORTER STATED THAT THE PATIENT DOES NOT BOLUS AT MEALS AND PATIENT IS STILL RUNNING LOW. THE REPORTER STATED THAT THEY WOULD LIKE PUMP REPLACED. CUSTOMER SUPPORT (CS) REVIEWED ALL SETTINGS AND ALL SETTINGS WERE FOUND TO BE CORRECT. THIS REPORT IS BEING MADE DUE TO HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343274 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR