BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4173699 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38339
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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

    INSPECTED 1 OPENED/USED SENSOR AND PERFORMED VISUAL INSPECTION; FOUND INSERTION NEEDLE BENT INSIDE SENSOR BASE. THE INSULIN PUMP WAS UNABLE TO CONFIRM CUSTOMER RECEIVED SENSOR IN THAT CONDITION DUE TO CUSTOMER RETURNING IT OPENED/USED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY CHANGED THEIR SITE AND THE INSULIN PUMP WAS ALARMING THRESHOLD SUSPEND. CUSTOMER STATED THAT THEIR BLOOD GLUCOSE READINGS WERE FLUCTUATING FROM THE 300 MG/DL RANGE TO 70 MG/DL RANGE. CUSTOMER STATED THAT THEY ATE LUNCH AND THE BLOOD GLUCOSE READING WAS 322 MG/DL AND THE CUSTOMER PROGRAMMED THE CARBS. CUSTOMER'S BLOOD GLUCOSE READINGS DECREASED TO 280 MG/DL WHEN THEY GOT HOME. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 163 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655822 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR