BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4251611 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52762
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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

    CUSTOMER REPORTED HAVING ISSUES WITH HER SENSOR. CUSTOMER STATED HER READINGS ARE AT LEAST 100 POINTS DIFFERENCE. CUSTOMER STATED THAT SHE SPOKE TO SOMEONE AT THE HOSPITAL AND WAS INFORMED IF BLEEDS TO MUCH IN A SPECIFIC AREA SHE SHOULD CHANGE THE AREA IN WHICH SHE WEARS THE SENSOR. CUSTOMER WAS CURRENTLY OF THE SENSOR. CUSTOMER STATED, THE INSULIN PUMP ALARMED SHE WAS LOW, HER BLOOD GLUCOSE WAS ACTUALLY 120 MG/DL, AND THE DEVICE WENT INTO THRESHOLD SUSPEND. TROUBLESHOOTING WAS NOT PERFORMED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737194 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR