BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3930673 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03741
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    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

    UNABLE TO CONFIRM THE NEEDLE COMPLAINT DUE TO CUSTOMER RETURNED THE SENSOR.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED THE NEEDLE BENT ON THE SENSOR. CUSTOMER'S MOTHER STATED THAT THE NEEDLE BENT WHILE TRYING TO INSERT THE SENSOR. NO BLOOD GLUCOSE LEVEL WAS PROVIDED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408895 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR