BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP LZG

    MDR report key: 3946645 · Received July 21, 2014

    Report

    Report Number
    2531779-2014-16568
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ANIMAS CORP
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ON 06/05/2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (CRACKED/DAMAGED CASING) ISSUE. THE REPORTER ALLEGED THAT THE CARTRIDGE COMPARTMENT WAS CRACKED/DAMAGED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305085 INSULIN INFUSION PUMP LZG PUMP, INFUSION, INSULIN LZG ANIMAS CORP ONETOUCHPING GLUCOSEMGMTSYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown