BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3023467 · Received March 27, 2013

    Report

    Report Number
    2531779-2013-03139
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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) 2013, THE REPORTER CONTACTED ANIMAS INDICATING THAT THE PATIENT IS IN THE HOSPITAL. THERE IS CURRENTLY NO INDICATION OF WHY THE PATIENT WAS IN THE HOSPITAL. THIS IS BEING REPORTED BASED ON THE INDICATION THAT THE PATIENT WAS IN THE HOSPITAL FOR AN UNKNOWN CAUSE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE EVENT A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125463 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization