BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3933447 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03788
    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 Location
    TX
    Reporter Occupation
    PATIENT

    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

    THE (B)(4) ANALYSIS INSPECTED 2 OPENED OR USED ENLITE SENSORS AND PERFORMED BICARBONATE BUFFER TEST (B)(4). BOTH SENSORS PASSED WITH ACCURATE READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S SENSOR WAS READING 40MG/DL AND RECEIVED A CALIBRATION ERROR. CUSTOMER VERIFIED AND HER BLOOD GLUCOSE READING WAS 207MG/DL AND SENSOR GLUCOSE READING WAS 57MG/DL. IN ANOTHER OCCASION, CUSTOMER'S SENSOR GLUCOSE READING WAS 57MG/DL AND BLOOD GLUCOSE READING WAS 228MG/DL. THE BLOOD GLUCOSE READING AT THE TIME WAS UNKNOWN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411144 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR