BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR

    MDR report key: 4141746 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33518
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    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

    CUSTOMER REPORTED THAT HE WAS NOT USING HIS SENSORS FOR THE LAST FEW MONTHS BECAUSE HE WAS HOSPITALIZED. THE CUSTOMER STATED HE WAS HOSPITALIZED FOR A FOOT ULCER THAT WAS DIABETES RELATED. THE CUSTOMER STATED HE WAS WEARING HIS INSULIN PUMP WHEN THE HOSPITALIZATION OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE WAS 87 MG/DL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621171 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization