BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2212064 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01676
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. 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 PROBLEM WITH SEVERAL SENSORS FROM HER LAST SHIPMENT. THE CUSTOMER STATED THAT THE ELECTRODE BROKE OFF UNDERNEATH HER SKIN ON ABOUT EIGHT OR NINE SENSORS. THE CUSTOMER WAS ABLE TO REMOVE THE ELECTRODES WITH TWEEZERS, BUT SHE DID NOT SAVE THEM. ADVISED THE CUSTOMER TO SAVE FUTURE SENSORS. 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

    Patients

    Seq Age Sex Outcome Treatment
    1