BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4241394 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50531
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ONE OPENED AND USED SENSOR WAS INSPECTED AND A BICARBONATE BUFFER TEST PERFORMED. THE SENSOR PASSED PER SPECIFICATIONS WITH ACCURATE READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S SENSOR WAS DAMAGED AT THE BASE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 325 MG/DL. STANDARD TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO CHANGE THE SENSOR AND INSERTION SITE. THE PRODUCT IS BEING RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722632 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG06G3D

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR