BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR HSA

    MDR report key: 3981978 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06118
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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

    IT WAS REPORTED THAT THE CUSTOMER'S SENSOR WAS SHOWING HER BLOOD GLUCOSE TO BE MUCH LOWER THAN HER METER READING. SHE STATED HER BLOOD GLUCOSE WAS 144 MG/DL WHILE THE SENSOR READING WAS IN THE 200 MG/DL TO 299 MG/DL RANGE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457563 SENSOR HSA CGM MDS MEDTRONIC MINIMED MMT-7003A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR