BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3954108 · Received July 23, 2014

    Report

    Report Number
    2032227-2014-04678
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE SENSOR SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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.

    Description of Event or Problem · 1

    TROUBLESHOOTING WAS DONE FOR CALIBRATION ERROR ALERT. BLOOD GLUCOSE LEVEL WAS 181 MG/DL. ALERT WAS VERIFIED. THE SENSOR WAS INSERTED ON (B)(6) 2014, ON THE RIGHT SIDE OF THE ABDOMEN AWAY FROM NATURAL BENDS. ALERT OCCURRED WHILE CUSTOMER WAS SLEEPING AND SITTING. CUSTOMER STATED THE ALARM DID NOT OCCUR SHORTLY AFTER PERFORMING A "FIND LOST SENSOR" OR AS A RESULT OF THE FIRST CALIBRATION ATTEMPT AFTER INITIALIZATION. CUSTOMER STATED THERE WASN'T AN INCORRECT OR DELAYED BLOOD GLUCOSE ENTRY. CUSTOMER WAS ADVISED TO USE A FRESH BLOOD GLUCOSE READING TO CALIBRATE. CUSTOMER CALLED BACK WITH REOCCURRING ISSUES. TROUBLESHOOTING FOR BAD SENSOR ALERT PERFORMED. BLOOD GLUCOSE LEVEL WAS 74 MG/DL. ALERT OCCURRED AFTER SECOND CALIBRATION ERROR ALARM, CALIBRATION PROTOCOL DISCUSSED. CUSTOMER WAS ADVISED TO CHANGE OUT SENSOR. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430935 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A E134U

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR