BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3120031 · Received May 20, 2013

    Report

    Report Number
    2531779-2013-06680
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PATIENT CONTACTED ANIMAS AND ALLEGED THAT HIS PUMP HAS NOT BEEN PUMPING OUT INSULIN CORRECTLY. THERE IS NO ADVERSE EVENT REPORTED RELATED TO THIS ISSUE. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PUMP IS NOT ACCURATELY DELIVERING INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222133 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR