BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942730 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04252
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT AGAINST THE SEN-SERTER. CUSTOMER RETURNED THE SENSER.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SERTER DEVICE DOES NOT FIRE AND THAT SHE CANNOT INSERT THE SENSOR. THE BLOOD GLUCOSE READING WAS NOT GIVEN. SHE WAS ADVISED TO ENSURE THE FOLD OVER FLAP WAS TUCKED UNDER THE SENSOR CONNECTORS BEFORE PLACING THE SERTER ONTO THE PEDESTAL. SHE WAS ADVISED THAT THE FOLD OVER FLAP MAY JAM THE SERTER IF IT IS MOVED OUT OF THE ASSEMBLED POSITION. CUSTOMER STATED THAT THIS FLAP WAS NOT DISLODGED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420209 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR