BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2211207 · Received July 11, 2011

    Report

    Report Number
    2032227-2011-01702
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ELECTRODE BROKE OFF UNDERNEATH HER SKIN WHEN SHE WAS REMOVING IT. THE CUSTOMER HAS MADE AN APPOINTMENT WITH HER HEALTHCARE PROFESSIONAL TO HAVE IT REMOVED. THE CUSTOMER REPORTED NO INFECTION. THE CUSTOMER HAD BEEN WEARING THE SENSOR FOR THREE DAYS. 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 C311

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR