BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3954495 · Received July 24, 2014

    Report

    Report Number
    2531779-2014-21213
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CONTACT ANIMAS ALLEGING THE PATIENT¿S BLOOD GLUCOSE WAS BETWEEN 250-499 MG/DL WITH VOMITING, SYMPTOMS OF DEHYDRATION, AND HEADACHE. IT WAS REPORTED THE PATIENT WAS TREATED IN AN EMERGENCY ROOM WITH INTRAVENOUS FLUIDS. THE REPORTER STATED, THE PATIENT WAS NOT ON PUMP THERAPY AT THE TIME OF THE EVENT SINCE THE PATIENT¿S HEALTH CARE PROVIDER ALLEGED THE PUMP WAS NOT DELIVERING CORRECTLY AND REQUIRED REPLACEMENT. THE PUMP WAS UNAVAILABLE AT THE TIME OF THE COMPLAINT AND TROUBLESHOOTING WAS UNABLE TO BE COMPLETED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT¿S REPORTED SERIOUS INJURY OCCURRED AFTER THE PATIENT DISCONTINUED PUMP-USE FOR AN ALLEGED UNKNOWN MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434372 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L