BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 3942720 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04234
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 COMPLAINED ABOUT HAVING FOUR SENSORS NOT FUNCTIONING PROPERLY. CUSTOMER EXPLAINED THAT TWO OF THEM COULD BE USED ONLY FOR TWO DAYS, ONE LASTED ONE DAY AND THE OTHER ONE WAS NOT READING. CUSTOMER STATED THAT HE INSERTED A NEW ONE IN THE MORNING AND IT IS WORKING. NO TROUBLESHOOT PERFORMED AS THERE WAS NO MALFUNCTION ON CURRENT SENSOR INSERTED. BLOOD GLUCOSE LEVEL 158 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418469 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C B064

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR