BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4220691 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31232
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED TO BE 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 AND ALLEGED THAT ON (B)(6) 2014, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) OVER 600 MG/DL WITH NAUSEA, VOMITING AND DIARRHEA. REPORTEDLY, THE PATIENT WAS HOSPITALIZED AND TREATED BY THEIR HEALTHCARE PROVIDER WITH INSULIN VIA THEIR PUMP AND IV FLUIDS. IT WAS REPORTED THAT THE PATIENT HAD A STOMACH VIRUS AND UNINTENTIONALLY REMOVED THE CAP IN THE MIDDLE OF THE NIGHT AND DISCARDED OF IT. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE PUMP AND NO ALARMS NOTED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA RELATED TO USE ERROR IN REMOVING THE BATTERY CAP FROM THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701338 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| L| R