BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3981381 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06076
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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

    ONE OPENED AND OR USED ENLITE SENSOR WAS INSPECTED AND TESTED. SENSOR FAILED PER SPECIFICATIONS DUE TO HIGH READINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A FALSE LOW BLOOD GLUCOSE ALERT ON THE SENSOR. HE STATED THAT WHEN THE SENSOR GLUCOSE READ 40 MG/DL, THE BLOOD GLUCOSE READING WAS 210 MG/DL. IT WAS DISCOVERED THAT THE CUSTOMER WAS OVERCALIBRATING. WHEN THE SENSOR READING WAS AT 61 MG/DL, THE BLOOD GLUCOSE READING WAS 178 MG/DL. HE STATED THAT THE DAY BEFORE, HIS BLOOD GLUCOSE READINGS WERE OVER 400 MG/DL WHILE THE SENSOR SHOWED IT TO BE AT 137 MG/DL. THE SENSOR WAS NOT TRENDING IN THE SAME DIRECTION AS THE BLOOD GLUCOSE. CUSTOMER WAS DELIVERING BOLUSES WITHOUT INPUTTING THE CARBS. THE CUSTOMER WAS UNABLE TO GET THE SENSOR TO FOLLOW THE BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457853 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR