BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 3841849 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02822
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. 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 HAD HIGH AND LOW BLOOD GLUCOSE. CALLER STATED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE SENSORS. CALLER STATED THAT THE INSULIN PUMP WAS ALARMING LOST SENSOR, CALIBRATION ERROR AND BAD SENSOR. CALLER ALSO STATED THAT WHEN CUSTOMER REMOVED THE SENSOR, THE CANNULA WAS BRAKED OPEN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319655 SENSOR OZO OZO MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR