BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4011458 · Received August 14, 2014

    Report

    Report Number
    2032227-2014-08307
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 CUSTOMER RECEIVED MULTIPLE LOST SENSOR ALERTS FROM TWO BOXES OF SENSORS FROM THE SAME BATCH. ON THE SIXTH DAY OF WEARING THE SENSOR, THERE WAS A SIGNIFICANT DIFFERENCE BETWEEN CUSTOMER'S SENSOR READINGS AND BLOOD GLUCOSE LEVEL. CUSTOMER'S LAST BLOOD GLUCOSE WAS 4.7 MMOL/L, BUT THE SENSOR READING WAS 3.9 MG/DL AND IT CAUSED THE INSULIN PUMP TO GO INTO SUSPEND MODE. THE SENSORS WILL BE REPLACED. CUSTOMER CONDUCTED TROUBLESHOOTING WITH THE US TEAM. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486392 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1