BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2241469 · Received August 9, 2011

    Report

    Report Number
    2032227-2011-02002
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 23, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CALLED TO REPORT MULTIPLE LOST RESERVOIR ALARMS. THE CUSTOMER ALSO STATED THAT WHEN HE REMOVED THE SENSOR FROM HIS BODY, THE ELECTRODE WAS BROKEN. THE CUSTOMER STATED THAT THIS HAS HAPPENED PREVIOUSLY WITH OTHER SENSORS. ADVISED THE CUSTOMER THAT THE SENSOR WOULD BE REPLACED. 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 E161

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR