BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELT CLIP

    MDR report key: 4250356 · Received November 7, 2014

    Report

    Report Number
    2032227-2014-48898
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IS IT 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. CUSTOMER STATES THAT THE BLOOD GLUCOSE READING IS 49 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718674 BELT CLIP MDS MEDTRONIC MINIMED MMT-612

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR