BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3933445 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03786
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    IT WAS REPORTED BY CUSTOMER'S MOTHER THAT THEY ARE HAVING MISCOMMUNICATION BETWEEN INSULIN PUMP AND SENSOR. SENSOR WAS REMOVED DUE TO INACCURATE READINGS. CUSTOMER'S MOTHER STATED, THEY RECEIVED MULTIPLE INACCURATE SUSPEND ALERTS. CUSTOMER ALSO NOTICED THE CANNULA WAS BENT ON THE SENSOR. CUSTOMER'S MOTHER STATED THEY RECEIVED CALIBRATION ERRORS; THEY WOULD WAIT FOR READINGS TO BECOME MORE ACCURATE FOR BETTER CALIBRATION. THE BLOOD GLUCOSE READINGS WOULD NEVER COME BACK WITHIN RANGE, IT WANTED TO SUSPEND ALL THE TIME. THE BLOOD GLUCOSE READING WAS 110 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410912 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR