BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3771826 · Received April 24, 2014

    Report

    Report Number
    2531779-2014-11273
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THE REASON FOR THE ADVERSE EVENT HAS BEEN ATTRIBUTED TO USE ERROR (PATIENT PRIMING WHILE ATTACHED). THIS

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2014 REPORTING THAT THEY PRIMED WHILE ON ATTACHED AND THEIR BLOOD GLUCOSE (BG) DROPPED QUICKLY FROM 250MG/DL TO 80MG/DL IN 45 MINUTES. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND TREATED BY A HEALTHCARE PROFESSIONAL. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED DUE TO THE PATIENT PRIMING WHILE ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250229 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization