BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 3945087 · Received July 18, 2014

    Report

    Report Number
    2032227-2014-04499
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 HIGH DIFFERENCE BETWEEN THE SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS. CUSTOMER STATED THAT HE HAS BEEN RECEIVING MULTIPLE LOW AND HIGH GLUCOSE ALERTS. DURING TROUBLESHOOT; GLUCOSE READINGS SHOWED A BLOOD GLUCOSE VALUE OF 150 MG/DL AND SENSOR GLUCOSE VALUE 143 MG/DL WITH DIFFERENCE PERCENTAGE OF 4.7%. CUSTOMER REPORTED HE HAD THREE BOXES OF SENSORS SOON TO EXPIRE ON (B)(6) 2014; CUSTOMER WAS ADVISED TO DISCARD SENSORS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421880 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C J132

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR