BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR BSA

    MDR report key: 3243656 · Received July 23, 2013

    Report

    Report Number
    2032227-2013-03102
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. PLEASE SEE ALSO MFR. REPORT NUMBER 2032227-2013-03078.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING A COUPLE OF SENSOR RELATED ERRORS. THE CUSTOMER ALSO REPORTED THAT HE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER WAS ADVISED OF PROPER CALIBRATION PROTOCOL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343723 SENSOR BSA CGM MDS MEDTRONIC MINIMED MMT-7002C D123

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization