BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2060574 · Received April 7, 2011

    Report

    Report Number
    2032227-2011-00879
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 26, 2011
    Report Date
    March 27, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO 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 SHE REMOVED THE SENSOR, AND THE ELECTRODE STAYED UNDERNEATH HER SKIN. ADVISED THE CUSTOMER TO SEEK MEDICAL ASSISTANCE TO REMOVE THE ELECTRODE. 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 J270

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR