BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4241462 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50513
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED SENSOR. PERFORMED BICARBONATE BUFFER TEST. SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS BETWEEN 300 MG/DL AND 400 MG/DL WHILE SHE WAS EATING. THE CUSTOMER WAS RECEIVED A BAD SENSOR ALERT AFTER TWO CONSECUTIVE CALIBRATION ERRORS. THE CUSTOMER MAY HAVE BEEN LAYING ON THE SENSOR AT NIGHT AND THE SENSOR CANNULA WAS FOUND TO BE A LITTLE BENT. A BLOOD GLUCOSE LEVEL OF 218 MG/DL WAS CAPTURED DURING SENSOR TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721872 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG07AN1

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR