BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3972082 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05102
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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 CALLED REPORTING BLEEDING AT THE SITE EVERY TIME SHE INSERTS A SENSOR. CUSTOMER'S BLOOD GLUCOSE WAS 136 MG/DL. CUSTOMER STATED THAT WHEN SHE INSERTS SENSORS, THE ENTIRE CLEAR PART FILLS UP WITH BLOOD. SHE WAS ADVISED TO APPLY PRESSURE FOR THREE MINUTES, AND TO REMOVE IF THE BLEEDING PERSISTS. SHE IS UNABLE TO TELL WHEN IT STOPS. SHE SAID THIS IS A NEW ISSUE WHERE EVERY SINGLE TIME THERE IS BLEEDING AT THE INSERTION SITE. SHE USES THE POOCH AREA, BUT THE SITE STILL ACTIVELY BLEEDS. SHE INSERTS IN THE ABDOMEN AREA. THE SENSORS WERE NOT PULLED OR TUGGED AFTER INSERTION. SENSORS ARE AWAY FROM RESTRICTIVE CLOTHING. CUSTOMER USES PROPER INSERTION METHOD. SHE FEELS PAIN DURING INSERTION, BUT IT GOES AWAY AFTERWARDS. CUSTOMER WAS ADVISED TO REVIEW INSERTION METHODS WITH HER DOCTOR. NOTHING FURTHER PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448346 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR