BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNESOR ENLITE

    MDR report key: 4130002 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26026
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 RECEIVING AN ALERT FOR LOW BLOOD GLUCOSE OF 48 MG/DL WHEN THE BLOOD GLUCOSE READING WAS AT 100 MG/DL. HE HAD ALSO RECEIVED A CHANGE SENSOR ALERT. HE REPORTED THAT THE HAD RECEIVED FALSE THRESHOLD SUSPEND ALARMS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585239 SNESOR ENLITE OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR