BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2161764 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01656
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 AN INFECTION AT THE SENSOR INSERTION SITE THAT REQUIRED TREATMENT BY HER DOCTOR. THE CUSTOMER STATED THAT SHE PREPARES THE SITE WITH ALCOHOL SPRAY, NO LOTION. THE CUSTOMER DISCARDED THE SENSORS THAT SHE GOT INFECTIONS WITH. 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 C141

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization