BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3933494 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03835
    Event Type
    Malfunction
    Date Received
    July 14, 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
    VA
    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. PLEASE SEE MEDWATCH REPORT # 2032227-2014-03816.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING ISSUES WITH THE SENSORS. CUSTOMER STATED THAT HE HAD USED THREE SENSORS AND ALL THREE WERE BENT WHEN HE TOOK THEM OUT BECAUSE OF LOST SENSOR ALARMS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 168 MG/DL. CUSTOMER STATED HE IS NOT SURE IF THERE WASN'T AN AREA WITHOUT SCAR TISSUE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411227 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG04NNM

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR