BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3945559 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04523
    Event Type
    Malfunction
    Date Received
    July 21, 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
    MI
    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

    IT WAS REPORTED THAT THE CUSTOMER REPORTED HE RECEIVED CALIBRATION ERRORS AND BAD SENSOR ALERTS. DURING TROUBLESHOOT; CUSTOMER STATED THAT SHE INSERTED THE SENSOR IN THE ABDOMEN USING THE SERTER AND IS FOLLOWING THE CALIBRATION RECOMMENDATIONS. CUSTOMER STATED THAT THE BAD SENSOR ALERT OCCURRED AFTER THE SECOND CALIBRATION ERROR AFTER INITIALIZATION. BLOOD GLUCOSE LEVEL 259 MG/DL; CUSTOMER TREATED WITH INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425032 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG01Y6J

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR