BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELT CLIP

    MDR report key: 4133533 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-09760
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. THE BLOOD GLUCOSE READING IS 43 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612364 BELT CLIP LZG MMT-640

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR