BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2021287 · Received March 7, 2011

    Report

    Report Number
    2032227-2011-00567
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 19, 2011
    Report Date
    February 19, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS TREATED BY PARAMEDICS DUE TO BLEEDING AT THE SENSOR SITE. THE CUSTOMER STATED THAT WHEN SHE REMOVED THE SENSOR, THE SITE BEGAN TO BLEED. THE CUSTOMER APPLIED PRESSURE TO THE SITE, BUT SHE CONTINUED TO BLEED FOR FORTY MINUTES. AT THAT POINT, SHE CALLED PARAMEDICS FOR ASSISTANCE. THE CUSTOMER STATED THAT SHE WAS NOT TAKING ANY BLOOD THINNERS AND THAT SHE HAD NEVER EXPERIENCED EXCESSIVE BLEEDING AT THE SITE PREVIOUSLY. 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 47 YR Required Intervention