BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 3933486 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03806
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN TO REPORT THAT HE WAS HAVING ISSUES WITH HIS SENSOR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL IS 134 MG/DL. THE CUSTOMER STATES THAT HE WAS GETTING CALIBRATION ERRORS, CHANGE SENSOR ALERTS, AND DISCREPANCIES WITH HIS SENSOR GLUCOSE VALUE AGAINST HIS METER GLUCOSE VALUE. WE ADVISED THE CUSTOMER THAT WE WOULD REPLACE THE SENSORS FOR HIM. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411014 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C B264

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR