BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3934368 · Received July 15, 2014

    Report

    Report Number
    2032227-2014-03917
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 STATED THAT THERE ARE VARIANCES WITH THE SENSOR GLUCOSE AND BLOOD GLUCOSE READING. THE BLOOD GLUCOSE STATED 40 MG/DL ON THE INSULIN PUMP, HOWEVER, AFTER THE BLOOD GLUCOSE WAS CHECKED THE CORRECT READING WAS 127 MG/DL. CUSTOMER USES TWO DIFFERENT GLUCOSE METERS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412086 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG02RWP

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR