BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4103469 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26362
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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. 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

    DURING A FOLLOW UP CALL THE CUSTOMER STATED THAT THE SENSOR DID NOT DETECT THAT THE CUSTOMER'S BLOOD GLUCOSE WAS ABOVE 500 MG/DL. THE SENSOR HAD BEEN INSERTED FOR ONLY THREE DAYS. THE CUSTOMER STATED THAT THE SENSORS WOULD NOT CALIBRATE AND THE SENSOR READINGS WERE DIFFERENT FROM THE BLOOD GLUCOSE READINGS. THE CUSTOMER COULD NOT RECALL EXACT VALUES. THE CUSTOMER ALSO STATED THAT SENSOR WOULD NOT GIVE PROPER WARNINGS. THEY HAD RECEIVED ALERTS THAT THE SENSOR NEEDED TO BE CHANGED, BUT DID NOT RECEIVE CALIBRATION ERROR OR NORMAL SENSOR END ALERTS. TROUBLESHOOTING WAS DECLINED. AT THE TIME OF THE PHONE CALL THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584099 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR