BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 3974115 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05257
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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.

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED/USED SENSOR AND PERFORMED A VISUAL INSPECTION; FOUND BENT ELECTRODE. THE SENSOR FAILED PER INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LOW BLOOD GLUCOSE OF 49 MG/DL. CUSTOMER CALLED IN STATING SHE WAS HAVING ISSUES WITH THE TRANSMITTER. TROUBLESHOOTING WAS PERFORMED AND DETERMINED TRANSMITTER IS FINE. TROUBLESHOOTING WAS PERFORMED FOR THE SENSOR. CUSTOMER WAS ADVISED TO CHANGE OUT SENSOR. THE SENSOR HAD A LITTLE CURVE TO IT. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451667 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C F104

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR