BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4000651 · Received August 11, 2014

    Report

    Report Number
    2032227-2014-07642
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    CUSTOMER REPORTED EXPERIENCING A HUGE DIFFERENCE BETWEEN THE SENSOR GLUCOSE READINGS VERSUS THE BLOOD GLUCOSE READINGS. CUSTOMER STATED THAT THEIR SENSOR READ 70 MG/DL WHILE THEIR BLOOD GLUCOSE READING WAS 175 MG/DL. CUSTOMER STATED THAT THEY EXPERIENCE THE DIFFERENCE WHEN THEIR BLOOD GLUCOSE READINGS ARE FLUCTUATING. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475463 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR