BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4173726 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-37778
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED/USED ENLITE SENSOR AND PERFORMED BICARBONATE BUFFER TEST. THE SENSOR PASSED WITH ACCURATE READINGS. ANALYSIS NOT REQUIRED BECAUSE IT CANNOT PERFORM OR REPRODUCE SKIN IRRITATION IN THE LAB. UNABLE TO CONFIRM NEEDLE BREAK AS CUSTOMER DID NOT RETURN NEEDLE SENSOR ONLY.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE RECEIVED A METER BLOOD GLUCOSE AND WHEN IT WAS ENTERED, SHE RECEIVED A CALIBRATION ERROR AND SENSOR ERROR. WHEN CUSTOMER ATTEMPTED TO TAKE SENSOR OUT, CUSTOMER STATES THERE WAS NO CANNULA ON SENSOR. CUSTOMER INDICATED THAT SHE DID NOT FEEL THE CANNULA ON HER SITE. CUSTOMER'S BLOOD GLUCOSE WAS 167 MG/DL. CUSTOMER WILL BE SENT A SENSOR AND TAPE KIT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654201 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR