BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAURDIAN REAL-TIME MONITOR

    MDR report key: 4210636 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43473
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    NURSE CALLED TO INFORM THAT THE CUSTOMER HAS HIGH GLUCOSE LEVELS OF 437 MG/DL, AND THE CUSTOMER'S INSULIN PUMP IS NOT ALARMING HIGH BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680772 GAURDIAN REAL-TIME MONITOR MDS MEDTRONIC MINIMED CSS7100NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR