BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR, MMT-7002C, 10PK, GLUCOSE, BSA, 17L

    MDR report key: 2031444 · Received March 14, 2011

    Report

    Report Number
    2032227-2011-00639
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 26, 2011
    Report Date
    February 26, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE CUSTOMER REPORTED A LOST SENSOR ALARM. THE CUSTOMER THEN STATED THAT THE CANNULA APPEARED TO BE SHORTER THAN USUAL. THE CUSTOMER WAS NOT SURE IF PART OF THE CANNULA BROKE OFF UNDERNEATH HER SKIN OR IF IT WAS LIKE THAT. ADVISED THE CUSTOMER TO SPEAK WITH HER DOCTOR TO HAVE THE SITE CHECKED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR, MMT-7002C, 10PK, GLUCOSE, BSA, 17L GLUCOSE SENSOR (PRODUCT CODE MDS) MDS MEDTRONIC MINIMED MMT-7002C A211

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR