BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3982301 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06142
    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 Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED SENSOR. PERFORMED BICARBONATE BUFFER TEST. SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.

    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 THE CUSTOMER HAD DIFFERENCES BETWEEN SENSOR GLUCOSE 40MG/DL AND BLOOD GLUCOSE 188MG/DL READINGS. CUSTOMER STATED RECEIVING THRESHOLD SUSPENDS AND BLOOD GLUCOSE IS NOT LOW. CUSTOMER STATED THE INSULIN PUMP WAS WORKING WELL PRIOR TO THE WEAK SIGNAL AND SENSOR ERROR. ADVISED TO REMOVE THE SENSOR AND CUSTOMER STATED THE SENSOR CANNULA WAS BENT. THE BLOOD GLUCOSE READING WAS 188MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457340 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR