BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3173099 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08326
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT'S FATHER CONTACTED ANIMAS AND ALLEGED THAT AT 8:00PM, THE PATIENT'S BLOOD GLUCOSE WAS 68 MG/DL AND THE PATIENT 'WAS OUT OF IT' AND WAS HEAD BOBBING. CUSTOMER SUPPORT VERIFIED ALL PUMP SETTINGS WERE CORRECT PER DOCTOR NOTES. THERE IS NO ALLEGATION OF PUMP MALFUNCTION. THIS COMPLAINT IS BEING REPORTED BECAUSE A PATIENT ON PUMP THERAPY EXPERIENCED HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274020 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening