BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4130274 · Received September 30, 2014

    Report

    Report Number
    2032227-2014-07764
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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. PLEASE SEE MEDWATCH REPORT 3004209178-2014-99596.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER WAS NOT WEARING THE SENSOR DUE THE SIGNIFICANT VARIATIONS BETWEEN THE SENSOR GLUCOSE AND BLOOD GLUCOSE READING. IN THE ALARM HISTORY THERE WERE WEAK SENSOR, PREDICTED HIGH BLOOD GLUCOSE AND PREDICTED LOW BLOOD GLUCOSE ALERTS. THE CUSTOMER'S BLOOD GLUCOSE WAS 173 MG/DL. THE CUSTOMER STATED THAT THERE WERE TWO SENSORS IN A ROW THAT WOULD NOT "LATCH ON" TO THE CORRECT RANGE WITH THE BLOOD GLUCOSE. THE CUSTOMER DECLINED TROUBLESHOOTING BECAUSE THEY WERE AT WORK. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607078 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR