BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3981768 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06081
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 2 OPENED AND USED SENSORS AND PERFORMED BICARBONATE BUFFER TEST PER SPECIFICATION. ONE OUT OF TWO SENSORS FAILED FOR HIGH READINGS. ONE REMAINING SENSORS PASSED PER SPECIFICATIONS WITH ACCURATE READINGS. ALSO FOUND BOTH SENSORS CANULA BENT. UNABLE TO CONFIRM CUSTOMER RECEIVED SENSORS IN SAID CONDITION DUE TO CUSTOMER RETURNING IT OPENED AND USED. UNABLE TO CONFIRM NEEDLE COMPLAINT DUE TO CUSTOMER RETURN SENSORS, BUT NO NEEDLES.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT DUE TO FLUCTUATING READINGS OF THEIR SENSOR GLUCOSE THEY PULLED OUT THE SENSOR FROM THEIR BODY AND NOTICED THAT THE CANNULA WAS SLIGHTLY TWISTED. ALSO, THE SITE OF INSERTION STARTED BLEEDING, BUT IT WAS NOT BLEEDING AT THE TIME OF THE CALL. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE CALL WAS 85 MG/DL. AT THE TIME OF THE PROBLEM THE CUSTOMER'S SENSOR GLUCOSE READINGS WERE 62 MG/DL, 45 MG/DL WHILE THE BLOOD GLUCOSE READING WAS 90 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING FOR THE SENSOR AND BLOOD GLUCOSE READING DIFFERENCES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457645 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR